Hours: Monday - Friday 8am to 5pm (might be a little flexible)
Duration: Direct Hire
Location: Carlsbad, CA
INTERVIEWING DECEMBER 26TH AND DECEMBER 30TH
Highly preferred experience
4-5 years of tablets, encapsulation and powders is very important
Nutraceutical experience
**For immediate consideration please send an updated copy of your resume to Megan at mmantlo@apexsystems.com with "R&D Technical Transfer Scientist" in the subject line**
Summary
Responsible for the successful technical transfer of product formulas from pilot lab to commercial equipment and through to cGMP production scale. Collaborate between R&D Team and Operations Team on formula development, providing technical expertise on reformulation needs through the product development process to achieve successful scale up. Create and maintain technical transfer documentation and history. Evaluate and refine product formulas as needed after commercial production, while maintaining customer requirements. Well versed on dietary supplement tablet, capsule and powder delivery formats.
Responsibilities:
Provide technical expertise and support to ensure successful transfer of customer formulas from concept to pilot lab and on to commercial equipment and cGMP production.
Collaborate with R&D Formulation Team and Technical Operations team on optimization of existing formulas to improve production efficiencies.
Be readily available to perform quick and timely adjustments to optimize production runs at all stages of the production process
Design and conduct appropriate formulation experiments to facilitate and ensure successful technical transfer of customer products to commercial production equipment, collaborating with R&D Formulation team, R&D Pilot Lab team and Director of Technical Operations.
Present relevant findings following technical transfer trials and formula adjustments to provide guidance to R&D Formulation and R&D Pilot Lab team as needed.
Provide technical expertise in review of initial formula concepts going through quoting process for any concerns around processability on commercial equipment
Collaborate with R&D Formulation Team on development of new product concepts that would be suitable for commercialization
Create and maintain relevant history and documentation on product formula transfer from pilot lab to commercial equipment
-Pilot lab trial reports
-Commercial equipment trial reports
-First commercial production reports
-Modifications to equipment settings, blend instructions, and formulas during product trials
Present technical transfer trial data/findings to senior management, Business Development and Client Management teams as needed
Create and/or act as additional R&D reviewer as needed to ensure accuracy and/or maintain accurate records of technical documents for product development projects, including but not limited to:
-Draft formulas
-Final formulas
-Product specifications
-Product justifications
-Master batch records
-Testing requests for finished products
-Testing requests for prototypes
-Document change requests for formulas
-Pilot batch records
Assist R&D Formulation team in evaluation of out-of-specification results on finished products
Act as an additional reviewer and signoff of formula formula-related documents for others on the R&D team
Maintain awareness of and update training as needed
-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
Follow efficient operations in assigned project areas in accordance with NAI requirements, SOP's and GMP's
Take leading role for projects as assigned
Works independently while understanding the necessity for effective communication and coordination of work efforts with cross-functional team and external partners
Participates in project meetings
Support other projects as needed within the formulation team
Raw Materials:
Collaborate with and assist R&D Formulation Team, R&D Technical Services Team, Purchasing and Quality with qualification and replacement of new and alternate raw materials and suppliers.
Collaborate with the R&D Formulation Team to identify raw material needs for prototypes and pilots for R&D Technical Services and Purchasing teams.
Collaborate on specification development with R&D Technical Services and Formulation teams.
Provide on-going internal and external technical support to ensure that production needs are met and customer requests are satisfied
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 R&D Formulation Team and 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 NAI teams
Present ideas and suggestions for 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 other science-related field
In-depth knowledge of formula development in hard shell capsules, tablets, powder fills and/or other dietary supplement dosage forms
Successful track record of developing/commercializing new products in manufacturing environment
Requires a minimum of five years direct industry formulation development experience, ideally with an additional three years of related experience
Possess comprehensive knowledge and practical experience with product/process development, and a firm foundation in chemistry, mathematics, pharmaceutics and/or food science
Proficient in oral and written communication skills as well as effective organizational skills and the 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 strong critical thinking, sound judgment, planning, organizing and problem-solving skills
Ability to work as a team member and interact at all levels
Supervisory Responsibilities
No direct supervisor responsibilities, but may guide and assign the work of others, such as technical support scientists, as well as provide technical guidance and support to formulation scientists.
Physical Demands
Manufacturing and general office environment
Exposure to disagreeable elements is negligible
Frequent work in pilot plant and production facilities
Training
Candidate ust 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
General office, pilot plant and manufacturing environment
A portion of the work will take place in the encapsulation, powder 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.)
**For immediate consideration please send an updated copy of your resume to Megan at mmantlo@apexsystems.com with "R&D Technical Transfer Scientist" in the subject line**