Associate Director Biotech Production

Location
Rensselaer, New York, United States of America
Posted
Jul 04, 2021
Ref
25078BR
Required Education
Bachelors Degree
Position Type
Full time
Summary: Directs all facets of production of recombinant proteins in Rensselaer

Essential Duties and Responsibilities include, but are not limited to, the following:
• Provides leadership, vision, and management to the manufacturing team.
• Directs manufacturing of recombinant proteins according to approved protocols, regulation and schedule.
• Develops schedules, detailed production plans and material requirements.
• Communicates well with supervisor of major problems regarding schedules and materials.
• Implements new recombinant protein production processes transferred by the Process Development team.
• Guides and oversees Validation activities involving Manufacturing equipment and processes.
• Interfaces with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
• Ensures the effective use of material, equipment and personnel in producing quality products.
• Formulates and recommends manufacturing policies, schedules, procedures and programs.
• Performs personnel management functions including scheduling of vacations, personnel development, and performance evaluations.
• Leads routine meetings to track key manufacturing and support activities.
• Recommends capital expenditures and aids in the realization of capital projects.
• Ensures that safety standards are maintained.
• Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
• Prepares and administers expense and capital budgets.
• Performs cGMP audits of production area.
• Represents manufacturing during regulatory and client audits.
• Provides technical input to resolve process problems.
• Develops and implements comprehensive manufacturing activities reports.
• Writes, reviews and/or approves Standard Operating Procedures, specifications, regulatory filing or other controlled documents as needed.
• Develops department goals, objectives and metrics.
• Works closely with staff to develop and manage individual goals and objectives.
• Leads and implements continuous improvement initiatives.
• Performs other tasks as required.

Education and Experience:
• Requires BS/BA in any of the physical or biological sciences, or chemical engineering, and 10 years of biopharmaceutical/biotech experience in a GMP production facility or equivalent combination of education and experience.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.