Chemistry Manufacturing and Controls (CMC)

RemX Specialty Staffing
Published
April 6, 2021
Location
Los Angeles, CA
Category
Job Type

Description

Employbridge Search Group has a client in Los Angeles, CA that is looking for a Chemistry, Manufacturing and Controls (CMC) with Food Technology experience to join their team! This company is growing, with lots of room for advancement and great benefits!

Job Duties

  • From conception to launch, contribute to new product development of conventional foods, functional food, meal replacements dietary supplements and medical foods
  • Research, develop, and/or review formulations for current and future products to ensure they meet claims food safety standards, and quality requirements while delivering the targeted nutrition rigorously in like with company's findings and science
  • Research, analyze and validate current and new ingredients, manufacturing processes, packaging and food technologies
  • Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents
  • Utilize formulation software to create and update formulations (ESHA Genesis)
  • Prepare product costings based on raw materials and manufacturing cost to ensure profitable products
  • Research new cost reducing manufacturing processes that meet customer and regulatory requirements
  • Design, conduct function and sensory evaluation of new ingredients, flavors and finished products including stability studies
  • Coordinate independent laboratory testing
  • Record, research and operational data, maintaining records of testing results and other documents as required by state or other governing agencies
  • Communicate effectively with relevant parties regarding food quality and safety concerns
  • Manage scientific or technical project resources (for example by ordering supplies to maintain inventories in laboratories)
  • Record, analyze, and summarize research data
  • Overall responsibility for all drug and food substance and product activities from pre-clinical development through clinical supplies for Phase 3 registration studies
  • Identification, selection and management of Contract Manufacturing Organization (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs
  • Develop and implement strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs
  • Formulation design/development for clinical programs
  • Management of supply chain and logistics in support of clinical studies
  • In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
  • Execute plans for the validation and registrations of API and DP as required by cGMP, ICH (international Conference of Harmonization) and FDA regulations
  • Writing and reviewing documents for INDs/regulatory selection submissions; represent the company as the CMC expert before U.S. and European regulatory authorities
  • Ensure adherence to GMP and other safety regulations
  • Other duties as assigned

Qualifications

  • Master of Science in food related science (e.g. food science/technology, food/chemical engineering, biochemistry)
  • Minimum of 10 years' experience in food chemist position
  • Work experience with dietary supplements and in the medical food category are highly recommended
  • Substantial experience in managing US and International CRO/CMOs for the manufacture of cGMP APIs an DP
  • Experience with cGMP manufacturing and IND, CTA, and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
  • Ability to identify and resolve critical issues
  • Implementing technical, strategic and operational plans
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