What are the responsibilities and job description for the MST Manager position at Cytovance Biologics?
Job Description :
The main responsibility of the Manufacturing Scientist is to support the manufacturing team as a technical advisor and operator. Manufacturing scientist adapt processes demonstrated at the R&D scale to the final manufacturing scale. Secondary roles include driving / contributing to continual improvement initiatives and providing input to production scheduling.
ESSENTIAL DUTIES AND RESPONSIBILITIES :
- Practice and promote safe work habits and adhere to safety procedures and guidelines.
- Demonstrate understanding in Good Manufacturing Practice and adhere to Quality standards and learn and comply with regulatory requirements.
- Exhibit proficiency in understanding concepts and scale-up requirements for all departmental disciplines with limited supervision required (listed below).
o Mammalian cell culture (suspension and adherent)
o Microbial cell culture (bacterial and yeast)
o Downstream Purification
o Gene Therapy (pDNA and AAV)
o R&D Process Descriptions
o Tech transfer document
o Batch records / Protocols
o Summary reports
o Collaborate on Material Specifications
o Author Temporary Changes
o Author Risk Assessments
o Author / Review Change Requests
o Initiate investigation reports.
o Execute corrective actions / preventative actions
o Supervise Manufacturing Sciences personnel.
o Coordinate with other production supervisors, managers, and project managers to execute production campaigns on time.
o Ensure batches adhere to established Quality standards.
o Conduct performance reviews of Manufacturing Sciences personnel.
o Provide input for hiring new manufacturing scientists and conduct interviews.
o Provide input for future growth of the group and budgeting.
o Engage in continuous improvement initiatives with production managers.
o Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues and improve process operations.
JOB REQUIREMENTS :
4 years of experience as a technical SME for manufacturing scale in a similar role. Biologics production is required.
PHYSICAL DEMANDS :
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand and sit. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and / or move up to 25 pounds.
WORK ENVIRONMENT :
While performing the duties of this job, the employee is rarely exposed to moving mechanical parts; toxic or caustic chemicals; and risk of electrical shock. The noise level in the work environment is usually moderate.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic's requirements prior to transmitting any Resumes / CV's or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic's Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.
