R&D Technical Transfer Scientist - Apex Systems : Job Details

Title: R&D Technical Transfer Scientist

Rate: $100K-$125k (Depedant on experience)

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 [email protected] 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 [email protected] with R&D Technical Transfer Scientist in the subject line**