MST Manager

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)
•    Transfer the process to Manufacturing.  This includes but is not limited to:
•    Adapting processes to manufacturing large scale with limited supervision required.
•    Provide suggestions for process optimization and efficiency, where applicable.
•    Perform Facility Fit analysis and work in conjunction with the engineering group to source new production equipment.
•    Ordering appropriate raw materials for the manufacturing process.
•    Authoring, reviewing, and approving technical documentation including but not limited to:
o    R&D Process Descriptions
o    Tech transfer document
o    Batch records / Protocols
o    Summary reports
•    Provide support during ongoing manufacturing campaigns by:
•    Perform data trending analysis
•    Troubleshooting issues with the ability to interpret process trends and data and react appropriately to unexpected outcomes
•    Interface with the Quality Assurance department to:
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
•    Group Management duties:
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.
•    Provide support to cross-functional teams to meet production or timeline demands. 
•    Represent the department to clients and on cross-functional project teams.
•    Train new staff in scientific concepts, technical operations, safety, and Good Manufacturing Practices.
•    Collaborate with vendors, and stay up-to-date on industry news, progress, and standards.
•    Participate in program meetings without supervision required
•    Review contract proposals and provide feedback pertaining to facility fit
•    Participate in Failure Mode Effects Analysis (FMEA)
•    Other duties as assigned

JOB REQUIREMENTS:

•    B.S. in life science or related degree required with laboratory experience preferred.
•    The ideal candidate will have 4 – 10 years of experience in GMP production or an advanced degree (MS or PhD) with 2 - 5 years of experience in GMP production.  
•    Must have >4 years of experience as a technical SME for manufacturing scale in a similar role.  Biologics production is required.
•    Proven track record of supervising a group of 4 employees in a biologics technical SME production environment (Manufacturing Sciences, Manufacturing Sciences and Technology, Process Engineering, etc) required.
•    Experience in early-phase and late-phase technical transfer and scale-up required.
•    Experience authoring GMP documentation required. 
•    Proficient technical writing skills required.
•    Proficient public speaking skills are required to translate general scientific and manufacturing concepts to a broad audience
•    Experience with production OIT software a plus (e.g. Unicorn, SCADA, Delta V, RS Batch, Pi Historian).
•    Must be proficient in Word and Excel.
•    Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently in a fast-paced team environment. 
•    Innovative, energetic, collaborative, quality-minded, detail-oriented, and dedicated to delivery on time. 
•    Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines. 

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.