Manager, Production; Manufacturing

MANAGER, PRODUCTION/MANUFACTURING (DOWNSTREAM), in Hopkinton, MA

Curia is a leading biologics company specializing in antibody and protein engineering, cell line development, and protein production. Our services can be fully integrated, creating a customized solution for all our customer’s molecular biology, cell line, and protein needs. 

We are rapidly growing and seeking a talented individual to join our team as the Downstream Process (DSP) Manufacturing Manager. As the head of Manufacturing, you will directly influence the culture and tone of our organization. You’ll be a go-to person for downstream GMP Manufacturing expertise for our Hopkinton, Massachusetts location and know your way around current industry trends.

We are looking for a motivated, and experienced downstream process development and manufacturing individual to lead DSP manufacturing team. We are looking for individual who understands process development and science related to purification.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

We proudly offer

• Generous benefit options (eligible first day of employment) 
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities 
• Education reimbursement
• 401k program
• Pension (for union employees)
• Learning platform

And more! 

Supervisory Responsibilities:

The manufacturing manager will be responsible for downstream personnel, overseeing day to day operations, and working closely with the process science department to ensure a seamless transition from development to manufacturing. The manufacturing manager will is responsible for downstream personnel, overseeing day to day operations, and working closely with the process science department to ensure a seamless transition from development to manufacturing. 

Essential Functions:

• Understands principles of chromatography and able to design steps to purify proteins to meet certain product specification
• High level understanding of cell culture process and processing steps. 
• Performs various chromatography and filtrations steps to deliver scalable and robust drug substances (DS) and drug products (DP) 
• Manages design and execution of DSP activity in 500 L plant.
• Plans, organizes, performs, and documents scientific experiments/plant activities.
• Meets quality, quantity, and timelines in all assigned projects.
• Contributes to project related scientific/technical activities under minimal guidance from more experienced team members. 
• Makes suggestions to improve work processes.
• Participates in cross functional technical team activities.
• Shares knowledge and expertise with others.
• Prepares and delivers presentations of project results to own or other groups.

Requirements

• BS required in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science
• Minimum of 4 years in a Manufacturing or related role within the biotech/pharmaceutical industry
• Leadership experience at or managing CDMOs a plus.
• Experience with mammalian and bacterial cell culture processes
• Experience with single use technologies and aseptic processing
• Knowledge of cGMP requirements with an understanding of phase-appropriate clinical and commercial expectations
• Experience as an author/contributor/reviewer of batch records, SOPs, technical protocols, data and final reports
• Experience in conducting risk assessment, root cause analyses, and impact analyses
• Experience in people management, resource allocation, and staffing strategies 
• Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
• Exceptional communication and interpersonal skills

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the uns