R&D Technical Transfer Scientist at Apex Systems, Inc. in Carlsbad, CA

Job#: 2057742

Job Description:

R&D Technical Transfer Scientist
Carlsbad, CA
Qualified Candidates should send their resume to [email protected].
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.
Essential Duties & 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, SOPs and GMPs

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

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

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.)

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 [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.