Job Description
Synopsis
This role is responsible for supervising commercial manufacturing production schedules. The ideal candidate will have a background in biotechnology and be able to lead a team of professionals in the manufacture of bulk drug substance in a cGMP regulatory environment.
Key Responsibilities
* Supervise commercial scale manufacturing of recombinant proteins according to approved protocols, regulations, and schedules.
* Lead all aspects of a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
* Maintain the highest safety and housekeeping standards.
* Review and edit batch records in line with cGMP standards.
* Ensure availability of production batch records for upcoming lots.
* Schedule duties and batch tasks based on master production schedules.
* Ensure equipment readiness and coordinate regular equipment maintenance and calibrations; troubleshoot equipment.
* Perform cGMP audits of production areas.
* Perform people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations.
* Schedule individual and ongoing training.
* Collaborate with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance, and Quality Control.
* Ensure that safety standards are maintained at all times.
Requirements
The ideal candidate will possess:
* Previous supervisory and leadership experience.
* An ability to work within a successful team.
Benefits
We offer a comprehensive benefits package, which may include:
* Health and wellness programs.
* Fitness centers.
* Equity awards.
* Annual bonuses.
* Paid time off for eligible employees at all levels.
Company Culture
We strive to maintain an inclusive and diverse culture where everyone feels valued and empowered to contribute their best work. We believe in fostering a positive work environment and encourage collaboration, open communication, and mutual respect among our teams.