MST Sr Scientist

Job Description:

GENERAL SUMMARY:

The primary responsibility of the Manufacturing Science and Technology (MSAT) Sr Scientist is to support the manufacturing team as a Technology transfer leader and technical advisor. Manufacturing scientist adapt processes demonstrated at the R&D scale to 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 practices and adhere to safety procedures and guidelines.
• Demonstrate a thorough understanding of current Good Manufacturing Practices, 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). 
  • Mammalian cell culture (suspension and adherent)
  • Microbial cell culture (bacterial and yeast)
  • Downstream Purification
  • Gene Therapy (pDNA and AAV)- preferred
• Transfer the process to Manufacturing.  This includes but is not limited to:
  • Adapting processes to manufacturing large scale with limited supervision.
  • 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:
    • R&D Process Descriptions
    • Tech transfer document
    • Batch records / Protocols
    • Summary reports
• Provide support during ongoing manufacturing campaigns by:
  • Performing 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:
    • Collaborate on Material Specifications
    • Author Temporary Changes
    • Author Risk Assessments
    • Author/Review Change Requests
    • Initiate investigation reports.
    • Execute corrective actions / preventative actions
• Provide support to cross-functional teams to meet production or timeline demands.
• Represent the MSAT 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 Biotech industry trends, progress, and standards.
• Participate in program meetings independently
• Review contract proposals and provide feedback pertaining to facility fit.
• Independently manage process transfer to late phase/commercial stage.
• Participate in FMEA analysis and PV documentation.
• Ensure batches adhere to established Quality standards.
• Engage in continuous improvement initiatives with production managers.
• Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues and improve process operations.

JOB REQUIREMENTS:

• An advanced degree (M.S. or Ph.D.) in Chemical Engineering or life sciences required with laboratory experience.
• The ideal candidate will have 4 – 10 years of experience in MSAT and/or GMP production with >5 years of experience as a technical SME for manufacturing scale in similar role.  Biologics production is required.
• Experience in early-phase, and late-phase technical transfer and scale-up required.
• Experience authoring GMP documentation required.
• Experience in FMEA and Root Cause analysis.
• Proficient technical writing skills required.
• Proficient verbal communication and presentation skills are required to translate general scientific and manufacturing concepts to a broad audience
• Experience with process validation and commercial manufacturing preferred.   
• 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, and detail-oriented, 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. The employee may 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; outside weather conditions, and risk of electrical shock. The noise level in the work environment is low to 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.