Associate Scientist, Preformulations
Position: Senior Scientist, Preformulations
Location: Boston, MA/On-Site
Company: Asymchem Boston Corporation
To Apply: Email cover letter and résumé to [email protected] Please include job title in the subject line.
Founded in 1999, Asymchem is a global integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies. Our mission is to drive smarter, greener, and more cost-effective manufacturing to support clinical research and commercialization. Asymchem currently operates eight manufacturing facilities offering solutions ranging from early clinical stage to commercial stage, including R&D, cGMP production of advanced intermediates, APIs, formulations, and clinical research services. Asymchem Group, headquartered in Tianjin, P. R. China. is a publicly traded company on the Shenzhen Stock Exchange (stock code 002821.SZ)
The salt and polymorphic form of a drug have a significant impact on bioavailability, purification of the drug substance, and stability of the drug substance. The preformulation group conducts salt and polymorph screens to determine optimal form and develops procedures to reliably crystallize the chosen form at scale. A senior scientist will conduct these screens, develop crystallization procedures, train junior scientists, and oversee the production of final reports and tech transfer documents.
Duties & Responsibilities:
- Display expertise in modern analytical techniques, such as particle size analyzers, dissolution instruments, XRPD, DSC, TGA, KF, DVS, PLM, and SEM.
- Solve complex issues of crystallization, purification, dissolution, and characterization of solid forms.
- Develop robust crystallizations for the target molecule which ensure safe, reproducible, and scalable manufacturing in large scale equipment.
- Will contribute directly to technology transfer to both internal and external groups.
- Collaborate with scientists within and outside functional area to achieve team goals.
- Contribute and participate in setting up the preformulations and analytical laboratories of Asymchem Boston’s new R&D center.
- Identify new technologies and execute implementation to improve productivity and work processes.
- Lead development projects including assignment of duties to junior staff, summarizing/interpreting data, solving technical problems, leading client meetings and achieving timelines and budgets.
- Effectively communicate own and team’s work. Effectively deliver project updates to the clients and the organization in oral or/and written forms.
- Keep abreast of relevant literature and maintain a high level of expertise in own field.
- Understand and manage IP position for a project.
- Supervise the work of junior scientists. This includes the responsibility for the appropriate motivating, coaching, mentoring, training, supervising, and developing the junior scientists.
- Ensure junior scientists have access to tools and information for career development opportunities and actively participates in employee growth and development. Plan and deliver on-the-job training.
- Perform laboratory operations in a safe manner. Ensure process safety guidelines are followed when conducting scale-up experiments. Keep abreast of the Chemical Hygiene Plan. Follow responsible actions for chemical disposal. Maintain compliance with all regulations at the federal, state, and local levels.
- Conduct other related duties as may be reasonably assigned.
Experience Requirements - Knowledge, Skills, & Abilities (KSAs):
- Ph.D. in chemistry or chemical engineering with 3+ years of experience in preformulations, tech transfer, and/or manufacturing in pharmaceutical companies or other relevant industries or Master’s Degree in chemistry or chemical engineering with 6+ years experience in preformulations, tech transfer, and/or manufacturing in pharmaceutical companies or other relevant industries.
- Experience of preformulations with demonstrated success in scaling processes.
- Knowledge of polymorphism, biodissolution, and Log P determination.
- Experience with particle size analyzers, dissolution instruments, XRPD, DSC, TGA, KF, DVS, PLM, and SEM.
- Ability to communicate effectively both in verbal and written forms.
- Must be able to work in a team environment; provide training and guidance to laboratory personnel.
- Excellent planning and organizational skills and the ability of multi-tasking and prioritizing in a highly dynamic environment.
- Previous supervisory experience is a plus.
- Experience and knowledge of GMP compliance and ICH quality guidelines is highly desirable.
- Must be fully vaccinated and boosted against COVID-19
- Day 1 Coverage for Medical, Vision (Co. Paid), and Dental Insurance
- Paid ~Life Insurance; Short-Term Disability (STD) & Long-Term Disability (LTD)
- Paid ~Holidays, Vacation, Sick Time, and Maternity Leave
- Matching 401K