GENERAL PURPOSE

Formulation development and optimization transfer of new product to manufacturing, and working cross functionally to ensure quality, safety, and regulatory compliance for all products manufactured.

Position Responsibilities:

• Lead the execution of various R&D functions.
• Engage in all phases of the Product Development process. These responsibilities include formula development, tech transfer to manufacturing, and post-commercialization manufacturing support.
• Initiate and execute innovation projects that expand the company’s product development capabilities and improve manufacturing efficiency.
• Support Sales by offering technical expertise in formula evaluation and customer communication
• Collaborate with the Quality Control Laboratory to ensure robust product & raw material specifications are in place to support manufacturing activities
• Work with Analytical Method Development scientists during development of material and finished product test methods
• Ensure products and processes are in compliance with all applicable Federal and State regulations
• Provide guidance and mentorship to junior scientists

All other duties assigned to the Research & Development Department, as needed

Minimum Qualifications:

Education: Bachelor of Science in a physical science or related field (e.g. Chemistry, Engineering, Pharmaceutics)

Experience:

4+ years experience developing products in a cGMP environment

Familiar with interface of R&D with manufacturing operations

People management experience

Knowledge, Skills and Abilities:

Preferred to have formulation experience in at least one of the following:

• Tablets
• Hard Shell Powder Capsules
• Gummies/Confectionary
• Powder Drink Mixes

GENERAL PURPOSE

Formulation development, oversight of process engineering and validation, and ensuring quality by design, safety, and regulatory compliance for all products manufactured.

Position Responsibilities:

• Initiate and lead projects to improve manufacturing efficiency or advance product innovation
• Provide guidance and mentorship to Formulation Scientist 1 and 2
• Product Development
  
  • Formula Quotation
  • Raw Material Specifications & Approval
  • Sample Generation
  • Formula Optimization
  • Sales Order Processing into a formulation that is approved for manufacturing
  • Composing Product Profiles
  • Process Design & Instruction
  • Batch Record Approval
  • Pilot Batch Manufacturing
  • Process Optimization

• Technical Sales Support
• Equipment Qualification & Process Validation
• Liaise with Quality Control Laboratory for Product & Raw Material Specifications
• Liaise with Method Development for Material and Finished Product Test Methods
• Regulatory Support for Compliance of all Applicable Regulatory Codes, Federal and State
• All other duties assigned to the Research & Development Department, as needed
  

Minimum Qualifications:

Education: Bachelor of Science in a physical science or related field (e.g. Chemistry, Engineering, Mathematics)

Experience: 4+ Years cGMP Required

Knowledge, Skills and Abilities:

Preferred to have formulation experience in at least one of the following:

• Tablets
• Hard Shell Powder Capsules
• Hard Shell Liquid Capsules
• Solutions
• Emulsions
  
  

GENERAL PURPOSE

Formulation development, oversight of process engineering and validation, and ensuring quality by design, safety, and regulatory compliance for all products manufactured with an emphasis on gummy products.

Position Responsibilities:

• Product Development
  • Formula Quotation
  • Raw Material Specifications & Approval
  • Sample Generation
  • Formula Optimization
  • Sales Order Processing into a formulation that is approved for manufacturing
  • Composing Product Profiles
  • Process Design & Instruction
  • Batch Record Approval
  • Pilot Batch Manufacturing
  • Manufacturing Process Scale Up and Optimization

• Technical Sales Support
• Equipment Qualification & Process Validation
• Liaise with Quality Control Laboratory for Product & Raw Material Specifications
• Liaise with Method Development for Material and Finished Product Test Methods
• Regulatory Support for Compliance of all Applicable Regulatory Codes, Federal and State

All other duties assigned to the Research & Development Department, as needed

Minimum Qualifications:

Education: Bachelor of Science in a physical science or related field (e.g. Chemistry, Engineering, Mathematics)

Experience: 2+ Years cGMP Required

Knowledge, Skills and Abilities: Formulation experience in gummy products

GENERAL PURPOSE

Formulation development, oversight of process engineering and validation, and ensuring quality by design, safety, and regulatory compliance for all products manufactured.

Position Responsibilities:

• Provide guidance and mentorship to Formulation Scientist 1
• Product Development
  • Formula Quotation
  • Raw Material Specifications & Approval
  • Sample Generation
  • Formula Optimization
  • Sales Order Processing into a formulation that is approved for manufacturing
  • Composing Product Profiles
  • Process Design & Instruction
  • Batch Record Approval
  • Pilot Batch Manufacturing
  • Process Optimization

• Technical Sales Support
• Equipment Qualification & Process Validation
• Liaise with Quality Control Laboratory for Product & Raw Material Specifications
• Liaise with Method Development for Material and Finished Product Test Methods
• Regulatory Support for Compliance of all Applicable Regulatory Codes, Federal and State

All other duties assigned to the Research & Development Department, as needed

Minimum Qualifications:

Education: Bachelor of Science in a physical science or related field (e.g. Chemistry, Engineering, Mathematics)

Experience: 2+ Years cGMP Required

Knowledge, Skills and Abilities:

Preferred to have formulation experience in at least one of the following:

• Tablets
• Hard Shell Powder Capsules
• Hard Shell Liquid Capsules
• Solutions
• Emulsions

GENERAL PURPOSE

Formulation development, oversight of process engineering and validation, and ensuring quality by design, safety, and regulatory compliance for all products manufactured.

Position Responsibilities:

• • Product Development

  - Formula Quotation

  - Raw Material Specifications & Approval

  - Sample Generation

  - Formula Optimization

  - Sales Order Processing into a formulation that is approved for manufacturing

  - Composing Product Profiles

  - Process Design & Instruction

  - Batch Record Approval

  - Pilot Batch Manufacturing

  - Process Optimization

  • Technical Sales Support
  • Equipment Qualification & Process Validation
  • Liaise with Quality Control Laboratory for Product & Raw Material Specifications
  • Liaise with Method Development for Material and Finished Product Test Methods
  • Regulatory Support for Compliance of all Applicable Regulatory Codes, Federal and State
  All other duties assigned to the Research & Development Department, as needed

Minimum Qualifications:

Education: Bachelor of Science in a physical science or related field (e.g. Chemistry, Engineering, Mathematics)

Experience: None (Entry Level), 2+ Years cGMP Preferred

Knowledge, Skills and Abilities:

Preferred to have formulation experience in at least one of the following:

• Tablets
• Hard Shell Powder Capsules
• Hard Shell Liquid Capsules
• Solutions
• Emulsions

Responsibilities:

• Designing, developing, and performing in-vitro viral assays
• Oversee culturing of cell lines including primary and transformed cell lines
• Research new methods and techniques for virus propagation and purification in BSL-2 and BSL-3 laboratory settings of new and/or problematic taxonomically diverse viruses
• Identifying, evaluating, and validating new technologies for measuring virus and viral components with accurate and precise concentrations
• Document research using GLP standards when appropriate to support new product design controls including validations, verifications, scale up and tech transfer to manufacturing, as well as technical and customer support departments
• Utilize statistical analysis
• Prepare reports with assay and production data
• Present data to wide audience

Qualifications:

• Must have either a M.S. or Ph.D. in relevant field of Virology, Microbiology, Molecular Biology, or Biochemistry
• The ideal candidate will also have a strong background in viral propagation and in-vitro assay development
• Experience with viral growth in BSL-2 and BSL-3 laboratory settings of taxonomically diverse RNA and DNA viruses and associated cell culture systems
• Ability to manage multiple projects concurrently to meet established deadlines
• Experience in managing virology responsibilities in a collaborative environment to achieve short- and long-term project goals
  
  

Responsibilities:

• Designing, developing, and performing in-vitro viral assays
• Oversee culturing of cell lines including primary and transformed cell lines
• Research new methods and techniques for virus propagation and purification in BSL-2 and BSL-3 laboratory settings of new and/or problematic taxonomically diverse viruses
• Identifying, evaluating, and validating new technologies for measuring virus and viral components with accurate and precise concentrations
• Document research using GLP standards when appropriate to support new product design controls including validations, verifications, scale up and tech transfer to manufacturing, as well as technical and customer support departments
• Utilize statistical analysis
• Prepare reports with assay and production data
• Present data to wide audience

Qualifications:

• Must have either a M.S. or Ph.D. in relevant field of Virology, Microbiology, Molecular Biology, or Biochemistry
• The ideal candidate will also have a strong background in viral propagation and in-vitro assay development
• Experience with viral growth in BSL-2 and BSL-3 laboratory settings of taxonomically diverse RNA and DNA viruses and associated cell culture systems
• Ability to manage multiple projects concurrently to meet established deadlines
• Experience in managing virology responsibilities in a collaborative environment to achieve short- and long-term project goals

The Client Management Assistant is responsible for providing administrative support to the Client Management team at a global supplement manufacturer. This primarily involves coordinating corporate marketing efforts/events as well as assisting Client Success Managers with PO processing and submission.

Essential Duties & Responsibilities

• Support Client Success Managers with administrative or project-based tasks, including but not limited to preparing PO checklists, change control documentation, customer open PO reports, Client price lists, etc.
• Reviews all incoming quote requests from sales, organizes the information submitted and publishes on server for processing
• Composes and prepares correspondence, reports and other complex documents
• Develops meaningful fact-based customer sales presentations under the direction of Client Success Managers or management.
• Routinely prepares agenda, notices, minutes and resolutions for meetings.
• Creates and maintains appropriate database and spreadsheet files necessary in supporting the department
• Manages programs, events, trade shows and conferences by arranging for facilities and caterer, issuing information or invitations, and coordinating speakers as assigned by management.
  
  

Qualifications

• Education and/or Experience: Bachelor's degree in Business Administration or related field preferred; or 3+ years related experience/training; or equivalent combination of education and experience
• Knowledgeable of Microsoft Office Outlook, Excel, Access, Word, PowerPoint, and MS Project
  
  

Responsible for planning, organizing, directing, and evaluating routine and non-routine activities of the QC chemistry staff in support of production and R&D and in full compliance with cGLP/cGMP regulations and company policies.

RESPONSIBILITIES

Principal responsibilities:

• Oversee the day to day chemistry operations to ensure that production and R&D needs are met.

• Plan the daily and weekly work assignments of the chemistry analysts.

• Collaborate with the lab administrative team and the manager to assign and revise testing priorities.

• Provides technical guidance to staff in the performance of all approved laboratory procedures.

• Review analyst work and notebook, prepare final reports. Ensure that proper record is kept both in printed and electronic forms. Ensure that accurate results are reported in a timely and appropriate manner.

• Evaluate and improve lab procedure in the chemistry lab.

• Performs out-of-specification (OOS) and out of trend (OOT) investigations.

• Communicate with other departments about samples and projects status.

• Perform data trend analysis for stability studies and communicate observations and conclusions to R&D.

• Manage the qualification, validation and maintenance program for all lab equipment.

• Provide technical leadership for instruments such as HPLC, GC, FTIR and ICP.

• Oversee the chemistry inventory to support effective lab operations.

• Communicate with contractors regarding lab equipment and with vendors regarding specialty consumables.
  
  

Supervisory responsibilities:

• Supervise the QC Chemistry staff to include hiring, training, scheduling, evaluating competency, mentoring, disciplining.

• Manage the training program for chemistry analysts in regards to laboratory procedures, analytical instruments and testing methodologies.

• Ensure that adequate and up-to-date training records are kept for each analyst.

• Oversee a proficiency testing program to monitor the efficacy of the training program.

• Review staff performance, address deficiencies and perform annual review assessments.
  
  

Safety responsibilities:

• Maintain a safe, organized and clean work environment in the chemistry lab.

• Assist in the management of the Chemical Control Program.

• Oversee the lab Chemical Hygiene Plan.

• Manage the lab hazardous material disposal program and oversee the proper disposal of all wastes.

• Maintain an up-to-date inventory of hazardous materials with regulatory agencies.

• Act as a QC representative to the Safety committee in rotation with the microbiology supervisor and lab manager.
  
  

Quality responsibilities:

• Maintain cGLP and cGMP standards and ensure that all procedures and policies are followed within the chemistry Lab

• Review and revise Standard Operating Procedures (SOP) and other quality documents.

• Participate actively in audits (internal and external) and in remedial actions for any non-compliance observations made in the chemistry lab.
  
  

Qualifications:

Education: BA/BS, MS or Ph.D. degree in chemistry or biochemistry.

Experience:

• Minimum 6 years (BA/BS) or 4 years (MS) or 2 years (Ph.D.) of analytical chemistry in a cGLP/cGMP lab is a must. Preferably in the dietary supplement, food or pharmaceutical industry.

• Minimum 2 years supervisory/leadership experience.

• Requires strong analytical and technical troubleshooting skills, especially with chromatography instrumentation such as HPLC. Ability to investigate and resolve chromatographic, physical and wet chemical issues.

Summary:

Develop and maintain formulations for a variety of dosage and delivery forms. Collaborate cross-functionally on formula development, formula-relevant documentation, raw material selection and evaluation, supplier qualification, and testing requirements.

Essential Duties & Responsibilities:

Formulation:

• Provide technical support within the formulation and cross-functional team
• Develop and review proposed formulas and associated ingredients

o Conceptualize and develop formulas suitable for commercialization
o Develop and maintain support substantiation for structure-function claims, nutritional, and technical information as required
o Act as secondary reviewer and sign off of formulas and formula-related documents from others on the R&D team
o Develop, update, and maintain formula substantiation based on regulatory feedback with regards to registration documents and labeling
o Responsible for reviewing and identifying solutions to out-of-specification results on finished products and communicate/collaborate with Quality team and/or customer to resolve

• Liaise with Purchasing team on R&D review of initial formula quotes prior to submission to Client Services
• Collaborate with R&D Technical Services Team on stability protocols and data

o Collaborate with R&D Technical Services team on development of stability protocols for products and evaluate stability data results
o Collaborate with R&D Technical Support team on stability monitoring, summaries, protocol revisions

• Design and conduct appropriate experiments for the pilot laboratory, collaborating with the Pilot Lab Supervisor, Pilot Lab Technicians, and Director of Technical Operations on pilot and manufacturing trials
• Maintain awareness of and update training as needed

o Proper use of laboratory and manufacturing equipment
o Development of new techniques, testing, and other areas related to product development

• Provide technical and scientific input, support and assistance to other technical disciplines
• Responsible for preparation and to ensure accuracy and/or maintain accurate records of all technical documents, and relevant development projects, including but not limited to:

o Draft formulas
o Final formulas
o Pilot quote spreadsheet
o Formula testing requirements
o Proposed nutrition/supplement facts panels
o Product specifications
o Product justifications
o Master batch records
o Testing requests for finished products
o Testing requests for prototypes
o Document change requests for formulas

• Review, collaborate on, and provide technical insights into, but not limited to, the following internal and/or external (i.e. customer) technical documents:

o Label copies
o Raw material specifications
o Material transfer requests
o Document change requests for raw materials
o Genesis reports
o Pilot batch records

• Take leading role for projects as assigned
  
  

Raw Materials:

• Collaborate with and assist Purchasing and Quality with the sourcing, qualification, and replacement of new and alternate raw materials and suppliers
• Identify raw material needs for prototypes and pilots for R&D Technical Services team
• Collaborate on specification development with R&D Technical Services team and Quality and Analytical Laboratory teams
• Responsible for reviewing and identifying solutions to out-of-specification results on raw materials and communicate/collaborate with Quality team and/or customers to resolve promptly
• Provide on-going internal and external technical support to ensure that production needs are met and customer requests are satisfied
• Provide and track ongoing finished product specification updates and compliance updates, due to regulatory or internal policy changes
• Manage and troubleshoot raw materials related products by understanding the potential ramifications caused by raw material and specification changes, such that appropriate actions are taken
• Build strategic relationships and maintain effective communications with vendors
• Foster professional knowledge of market and supplier information
• Collaborate with Purchasing as needed to help support a consistent supply of our raw materials, as well as avoid market price fluctuations
  
  

Qualifications:

• Requires a four year college/university degree or its equivalent in Pharmacy, Chemistry, Food Science, Chemical Engineering, or related field
• Must have computer literacy, including word processing and spreadsheet software
  
  

Summary

Responsible for managing assigned client accounts. Responsible for order processing and management, project management of new products and existing product changes, sales forecast management, pricing management, developing and maintaining client accounts, internal cross functional team and business partner relationships. Acts as a liaison between clients and cross-functional internal teams to ensure the timely and successful delivery of communication and solutions according to client needs. Responsible for coordinating internal functions to ensure customer needs are met and ensure client satisfaction. Drives and manages the New Product Implementation process by working with internal cross-functional groups on assigned new product launch projects. May be required to give client tours and presentations as needed, travel to client facilities and/or industry trade shows/conferences.

Essential Duties & Responsibilities

• Problem solves both internally and externally to manage client projects and formulate responses to client complaints, documentation and/or information requests.
• Responsible for managing and developing client accounts to maintain favorable client relationships and help clients succeed in their business goals.

• Responsible for working with the Business Development managers to onboard and integrate new clients and develop existing client relationships.

• Liaison between the client and internal teams. Responsible for communicating internal feedback directly to the client.

• Manages the planning and coordination of new product development by driving the new product implementation process; assumes the role of project manager coordinating a core cross-functional peer group to ensure the successful launch of new products from quote acceptance through small scale development, commercial production and shipment.

• Follows through with phone contact and necessary correspondence with existing clients or new sales to include order processing, acknowledgements and order status.
• Ensures that clients receive promised deliveries as specified through contract or order acknowledgement.

• Successfully manage multiple projects simultaneously without missing critical deadlines.

• Meets and confers with clients both on and off-site. Gives presentations and tours as needed.

• Inputs, analyzes, and manages sales forecasts and works with other departments and clients to ensure sales projections are routinely met; reports monthly on account sales performance based on analysis and as request by management.
• Drives new sales growth opportunities of existing accounts by working in conjunction with the Business Development Managers and providing supporting information and documents to educate clients on new market opportunities as well as building and maintaining strong customer relationships.
• Through self-initiated research, continuously increases and updates knowledge of industry, trends, regulations, client trends and domestic and global issues that impact the clients and/or our business.
• Knowledgeable and maintains compliance with applicable standard operating procedures.
• Participates in the development of and must remain knowledgeable as to the terms of all client contracts such as supply and quality agreements; responsible for due diligence in ensuring compliance with the terms of such contract(s).
  
  

Qualifications

• Bachelor's degree is preferred. Master’s degree is a plus. Will consider candidates with a high school diploma and 5+ years of experience in sales, account management or client success management in a client-centric work environment.

• Must be able to develop and sustain positive relationships with key client contacts in this position.
• Must maintain confidentiality of company financial and other sensitive and proprietary information.
• Must be computer literate and able to demonstrate proficiency in MS Word, Excel, PowerPoint, Outlook, Project, Zoom and Microsoft Teams.
• Must possess strong organizational and time management skills; able to maintain flexibility in response to fast- paced environment with constantly changing priorities and successfully manage multiple projects simultaneously without missing critical deadlines.
  
  

Summary:

• Perform routine and non-routine analysis of raw, in-process and finished products using various analytical methodologies (chromatography, spectroscopy, physical and chemical separation techniques). Process, interpret, trend and report testing results in a timely and professional manner. Investigate and document out-of-trend and out-of-spec results. Assist with methodology review and improvement efforts. Comply with all applicable regulations and policies.
  
  

Essential Duties & Responsibilities:

• Perform routine and non-routine testing of raw materials, in-process and finished products and stability samples in support of production and R&D.
• Conduct analytical (HPLC_UV, UPLC_MS/MS, ICP_MS, GC_MSMS, HPTLC, UV, FTIR), physical (LOD, weight uniformity) and chemical (Karl Fisher, pH, titrations, USP monographs) analysis per established lab SOPs.
• Perform testing with accuracy and precision; maintain accurate and detailed records.
• Prepare sample, standard and reagent solutions as required by the test methods.
• Handle and store all chemicals according to safety guidelines. Ensure that chemicals are within their respective shelf life.
• Assist in the maintenance of an up-to-date and accurate chemicals and supplies inventory.
• Monitor the stability of reference standards used in the quantitative assays.
• Operate and maintain general laboratory equipment (pipettes, pH meters, analytical balances…) and instruments (IR, HTLC, UV, HPLC_UV, UPLC_MSMS, ICP_MS, GC_MSMS).
• Troubleshoot instrument errors as needed. Ensure that adequate documentation is kept in the appropriate equipment logbook. Promptly report incident to supervisor.
• Communicate testing status in a timely and effective manner to management and lab coordinators.
• Process and report testing data in a timely manner, submit to a chemist for peer review and then to management for final approval.
• Perform peer review of data and reports generate by other analysts.
• Performs out-of-specification (OOS) investigations and create OOS reports as needed for raw materials and finished products.
• Monitor overtime data obtained for a given matrix to identify out-of-trend results and/or systemic issues.
• Process stability studies data and evaluate if the results are satisfactory to establish stability trends.
• Ensure that all the necessary documentation is completed for each sample. Carefully enter all pertinent data in analyst notebooks, electronic databases (E-boards, Access), test request forms and lab reports.
• Perform basic instrument maintenance per in-house procedures, facilitate adherence to calibration and qualification SOPs.
• Assist in efforts to develop and validate new analytical methods and/or to improve existing methods.
• Periodically review lab SOPs and revise documents as needed to ensure that they are accurate and adequate training tools.
• Participate in the waste disposal program of the lab hazardous materials.
• Learn and demonstrate proficiency in new analytical methodologies as assigned by the supervisor.
• Train chemistry technicians and associate chemists on instrumentation, methodologies, and lab SOPs.
• Comply with cGMP, cGLP, and other applicable government regulations; as well as company compliance guidelines, standards and objectives.
  
  

Qualifications:

• Bachelor’s in Chemistry, Biochemistry, Chemical Engineering or related science degree.
• Minimum 3-5 years hands-on experience in an analytical lab with either the dietary supplement, pharmaceutical, or food and beverage industry.
• HPLC experience required (familiarity with Waters instruments HPLC, UPLC, and Empower software desirable).
• MS experience highly desirable (ICP/MS, GC/MS/MS, HPLC/MS, or UPLC/MS/MS).
• Experience with cGMP and cGLP required.
  
  

Job Responsibilities

The purpose of this position is to assist in the cost accounting function and support the maintenance of the Standard Cost System. This will include maintenance of routers and month end closing activities that support the cost accounting group responsibilities:

• Perform month end close activities
• Assist with month end reporting
• Work with operations to maintain / update production routers
• Establish cost roll standards for new and revised finished and semi-finished items
• Annual standard cost setting duties
• Assist with manufacturing variance analysis and reporting
• Complete monthly Purchase Price Varince (PPV) reserve analysis
• Item setup and maintenance
• Perform manufacturing time studies
• Special cost projects or other ad hoc projects
• Maintains Sarbanes-Oxley process documentation and ensures continued compliance with internal controls requirements
  
  

Qualifications

• Must have a B.A. or B.S. degree in Accounting
• Preferably has a minimum of 2 years of cost/operations related experience in a manufacturing company
• Must have a solid understanding of accounting rules and methods
• Microsoft Office proficient, including intermediate Excel skills, such as proficiency with pivots and lookups
• Experience with ERP/MRP Manufacturing & Financial Software preferred
• Familiarity with BOMs and Router maintenance preferred