Candidate will need to be a hands-on, motivated self-starter with strong initiative. Candidate will be responsible for developing and performing various assays for product and process development. Candidate will be required to work both in the laboratory or the pilot plant environment as needed. In addition, this role will also provide support to the development of new nutritional and drug product development, including support of the clinical material production.
In addition, this role will also provide support to the development of new nutritional, drug and cosmetic product development, including support of the clinical material production. The successful candidate will coordinate with research and development, manufacturing and quality teams to meet the process and product endpoints and to ensure that the output meets design inputs and can be reliably produced.
Primary Duties and Responsibilities
· Designs experimental plans, analyzes experimental data, generates laboratory protocols, and provides summaries
· Supports formulation process and product development and characterization procedures
· Cultivates a strong understanding of materials for formulation and perform creative research that incorporates them into a diverse line of products
· Prepares and executes method development report, method validation protocol and validation report for molecular biology experiments, including nucleic acids preparation and routine analysis of QPCR in high-throughput manner
· Troubleshoots and solves difficult problems in the design/execution of development projects
· Issues product specifications as required and maintain relevant data throughout each process and product’s development.
· Identifies and understands variations in product, equipment and procedures which may affect results.
· Works with R&D team to set up procedures for pilot and production scale-up.
· Maintains working knowledge of all stages of finished goods production and all pertinent documentation.
· Maintains accurate lab notebook to support protection of intellectual property
· Prepares and implements SOPs through Change Control process.
· Supports R&D new product development, including pilot scale studies, as well as GMP production support.
· Tracks, orders and maintains laboratories supplies to assure analyses can be performed without delay.
· Perform and improve molecular biology assays including QPCR on digital platform and other protein-based assays
· Design, develop and improve topical products and adaptably approach new problems in a way that complements our fast-paced growth environment
· Responsible for the performance testing of product developed including stability and any other required testing
· Responsible for creating procedures for chemical and product testing
· Identify new or improve formulation technologies and implement them to meet project needs.
· Attentive to detail, analytical, and process driven with ability to operate in a complex or matrixed work environment
· Good time management.
· Strong teamwork, and organizational skills
· Strong initiative and self-starter
· Excellent interpersonal, communication, presentation, and organizational skills
· Proficiency in Microsoft Office (Power Point, Word, Excel, Access, Visio)
· Flexible with work hours which include some mandatory early morning and late-night shifts
· MS in Molecular Biology, Biochemistry, Biotechnology, Microbiology, Chemistry or other applicable related fields, with minimum 3 years of experience working in regulated laboratory on related activities or BS with minimum 5 years of experience
- · Experience with cosmetic or topical production formulation and development is a plus
· Ability to work independently or as a team to meet deadlines
· Detail oriented with critical thinking ability
· Adaptability and positive attitude
· Ability to multi-task
Other Knowledge, Skills and Abilities
· Familiar with formulation development, rheology, stability Testing, and other relevant characterization methods of topical cream formulations
· Prior work on molecular biology assays including QPCR and Protein analysis
· Prior research on milk bioactive compounds, including quantification of bioactive compounds from human milk are preferred.
Work Environment (Location, travel, shift, on-call, etc.)
City of Industry, California
· Must be able to perform duties within clean-rooms, requiring to push, pull, and lift equipment up to 25 pounds while full gowned.
· Work in ≤ -20 degree Celsius for short periods of time to retrieve raw and finished material from the freezer.
a. Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.
Amount of Time
Up to 1/3
1/3 to 2/3
2/3 or more
Talk or hear
Use hands to finger, handle or feel
Climb or balance
Stoop, Kneel, crouch or crawl
Reach with hands and arms
Taste or smell
b. Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.
Amount of Time
Up to 1/3
1/3 to 2/3
2/3 or more
Up to 10 pounds
Up to 25 pounds
Up to 50 pounds
Up to 100 pounds
More than 100 pounds