R&D Formulation Team Manager

R&D Formulation Team Manager

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Title: R&D Formulations Team Manager

Location: Carlsbad, CA

Direct Hire

Summary
Manage and track R&D Formulation team and Formulation team projects and priorities. Develop 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. Provide technical expertise and support to other members of R&D team, including formulation scientists, coordinators and specialists.
Essential Duties & Responsibilities
Formulation:

• Manage and provide scientific leadership for the R&D formulation team
• Provide and discuss with R&D management quarterly metrics and/or relevant analyses for formulation team
  • Project tracking - formulas such as quote formulas, benchtops and pilots, deadlines met and missed
  • Process/project gap analysis
• Manage development and review of proposed formulas and associated ingredients
  • Manage conception and development of formulas suitable for commercialization
  • Manage and support substantiation for structure-function claims, nutritional, and technical information as required
  • Manage and secondary signoff for formulation team formulas, nutrition/supplement facts panels, raw material specifications
  • Manage formula development and substantiation based on regulatory feedback with regards to registration documents and labeling
  • Liaise with Purchasing team on R&D review of initial formula quotes prior to submission to Client Services
• Manage formulation team in preparation of stability protocols and evaluation of stability data for products
  • Collaborate with R&D Technical Support team on stability monitoring, summaries, protocol revisions
• Manage design and conduction of appropriate experiments for pilot lab, collaborating with Director of Technical Operations on pilot manufacturing trials
• Manage and ensure training of formulation team:
  • Proper use of laboratory and manufacturing equipment
  • Development of new techniques, testing, and other areas related to product development
• Provide technical and scientific input, support and assistance to other technical disciplines
• Manage preparation, and ensure accuracy and maintenance of records of all technical documents and relevant development projects from formulation team, including but not limited to:
  • SOPs
  • Draft formulas
  • Final formulas
  • Proposed nutrition/supplement facts panels
  • Label copies
  • Raw material specifications
  • Product specifications
  • Product justifications
  • Master batch records
  • Testing requests
  • Material transfer requests
  • Document change requests
  • Technical reports
• Ensure efficient operations in assigned project areas in accordance with the client's requirements, SOP's and GMP's
• Take leading role for projects as assigned
• Manage and support other projects as needed within formulation team

Raw Materials:

• Manage Formulation team and prioritize qualification of new and replacement raw materials and alternate suppliers
• Collaborate with and assist Purchasing and Quality teams with the sourcing, qualification and replacement of new and alternate raw materials and suppliers
• Manage specification development in conjunction with R&D Technical Support team and Quality and Analytical Laboratory teams
• Provide on-going internal and external technical raw material support to ensure that production needs are met and customer requests are satisfied
• Manage ongoing specification updates and compliance updates, due to regulatory or internal policy changes
• Manage and troubleshoot raw materials related projects 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 Formulation team with regards to market and supplier information, including regarding the potential impact of material changes in a global economy
• Collaborate with Purchasing as needed to help support a consistent supply of our raw materials, as well as avoid market price fluctuations

Other Duties

• Maintain awareness of current developments within the functional discipline.
• Develop a network of outside contacts such as vendors, consultants, educators, and attend appropriate continuing education courses.
• Collaborate with and support cross-functional teams.
• Present ideas and suggestions for new products, product or process improvements, and improvements to pilot laboratory operations.
• Perform other related duties as assigned.

Qualifications

• Requires a four year college or university degree or its equivalent in Pharmacy, Chemistry, Food Science, Chemical Engineering or related field
• Requires a minimum of seven years industry formulation development experience with five years of related experience
• Possess comprehensive knowledge and practical experience with product/process development, processing laboratory techniques and regulatory requirements, and a firm foundation in chemistry, mathematics, pharmaceutics and/or food science
• Proficient in oral and written communication skills as well as effective organizational and supervisory skills
• Ability to make presentations and recommendations in the area of responsibility
• Must be able to communicate effectively in a cross functional team environment and have the ability to statistically analyze data
• Must have computer literacy, including word processing and spreadsheet software
• Must have sound judgment and decision-making skills

Supervisory Responsibilities

• Supervises, guides, and assigns the work of others (formulation scientists, technicians, and assistants)

Physical Demands

• Manufacturing and general office environment
• Exposure to disagreeable elements is negligible
• Frequent work in pilot plant and production facilities

Training

• The incumbent must be able to perform this job safely in accordance with standard operating procedures and good manufacturing practices, without endangering the health or safety of self or others

Work Environment

• Primarily in a general office environment
• A portion of the work will take place in the encapsulation and/or tableting areas of the manufacturing facility, where one will be exposed to computerized equipment, moving mechanical parts, forklifts, heavy pallets, moderate to loud noise level, and air-borne dust and powders
• While working in the manufacturing area, one will be required to wear various personal protective equipment (e.g., clothing, hair net, face mask, gloves, goggles, etc.)

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or