Sr Manufacturing Chemist

Longmont, Colorado, United States Full-time

Position Title: Sr Manufacturing Chemist – API
Job Location(s): Longmont, CO
Start Date: ASAP
Employment Type: Full Time
Starting Salary Range: Competitive; based on experience
Job Requisition #: 18019

Avista Pharma Solutions is a contract testing, development and manufacturing organization (CDMO) encompassing over 200,000 square feet of laboratory and manufacturing space across three locations (Agawam, MA – Durham, NC – Longmont, CO), providing pharmaceutical, animal health and medical device clients with a broad suite of scientifically-differentiated services.

DUTIES:

  • As Manufacturing Chemist – API, you will execute GMP and non-GMP manufacturing production of intermediates and drug substance.
  • You will write and execute batch records, review SOPs, and maintain quality documents associated with manufacturing.
  • You will perform and execute scale-up activities for large scale GLP / GMP manufacturing projects, including familiarization and front run execution.
  • You will perform laboratory scale experiments in support of GLP / GMP manufacturing projects.
  • As Manufacturing Chemist, you will review GMP documents (batch records, SOPs, etc.) according to regulatory and procedural guidelines.
  • You will coordinate the activities of Manufacturing Technicians.
  • Additionally, you will work with Manufacturing and Quality management to resolve manufacturing problems.
  • You will develop and maintain quality documents in support of manufacturing (CAPAs, Change Control, Unplanned Changes, etc.).


QUALIFICATIONS:

  • Minimum of BS Degree with 2+ years of related GMP experience or MS Degree with 1+ years of related GMP experience or equivalent industry experience.
  • Advanced degree in Organic Chemistry preferred.
  • Experience with FDA audits preferred.
  • Good knowledge of GMP for API, Drug Product, and Drug Substance.
  • Good knowledge of HPLC, GC, NMR, and other methods of compound characterization.
  • Previous experience in a GMP or highly regulated manufacturing environment.
  • Experience with manufacture and handling of highly potent APIs a plus.

 
SUCCESS FACTORS:

  • Communicate well with internal customers, team members, and external customers.
  • Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization.
  • Excellent verbal and written communication skills.
  • Ability to write reports and business correspondences.
  • Ability to listen and respond well to external customers, partners and colleagues at all levels.


Avista Pharma Solutions is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.