Scientist, CMC
- Employer
- Sci.Bio
- Location
- Lexington, MA
- Start date
- Jun 18, 2019
View more
- Discipline
- Engineering, Chemical Engineer, Manufacturing & Production, Science/R&D, Chemistry
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Description
We are seeking a highly motivated and scientifically rigorous individual to join our team as a Scientist, CMC. The successful candidate will report to the Associate Director, CMC and be an integral part of the CMC team. The position will focus on drug substance and drug product manufacturing, regulatory and analytical support, including development, validation, and data review for drug substances and drug products. The position will develop and execute scalable and robust formulation processes for drug substance and drug product and help serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.
Responsibilities
Lead technology transfer of mRNA and nanoparticle manufacturing processes to internal and/or external manufacturing partners
Design and conduct experiments to facilitate and support scale up of drug substance and drug product manufacturing processes. Design experiments to evaluate and assess critical process parameters for scale up of drug substance and drug product manufacturing.
Lead and support startup of GMP manufacturing equipment including factoring acceptance testing, site acceptance testing, and/or IQ/OQ/PQ testing.
Prepare technical reports and presentations that support scale-up activities and process improvements
Design and conduct experiments to investigate the impact of formulation parameters on drug product processes
Identify solutions, including process analytical technologies, which lead to robust process control strategies
Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality
Support and contribute to IND filings/regulatory documentation
Required Skills
A Bachelor’s or Master’s degree in Chemistry, Chemical engineering or Biochemistry is required
5-10 years of experience working in a pharmaceutical or biotechnology company is required. A minimum of 3 years working in a GMP environment is preferred.
Demonstrated experience in process development/scale-up of drug product formulation is required
A familiarity and hands-on experience with the development of novel drug carriers using nanoparticle formulations is required
Experience with analytical tools for release and characterization of drug product processes and drug products is required
Demonstrated ability to apply fundamental scientific and engineering skills for evaluation of processes and development of practical solutions to technical challenges is required
Must have experience working with GMP pharmaceutical manufacturing unit operations, including drafting batch records, standard operating procedures, and/or protocols.
Familiarity with cGMP, ICH and regulatory guidelines
Ability to partner with CROs/CMOs
Excellent organizational and communication skills
Strong operational execution and problem-solving skills are desired
Desire to work in a fast-paced, deadline-driven environment
Excellent organizational and communication skills
Strong analytical and problem-solving skills
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