Staff Process Specialist, Manufacturing

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 92,200 - 206,100; Full time

Benefits offered by this job

Health and wellness programs

401(k) company match

Paid time off

Annual bonuses

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Staff Process Specialist in Manufacturing. The role involves providing technical input to resolve process problems, coaching personnel, and implementing continuous improvements in line with cGMP standards.

The ideal candidate will possess strong interpersonal skills and a relevant degree in Life Sciences, with significant experience in the cGMP manufacturing environment.

A competitive salary range of $92,200 - $206,100 annually and various benefits are offered.

Qualifications

• Keen knowledge of cGMP manufacturing environment.
• Technology transfer and equipment/process validation experience is preferred.
• Experience with operating and qualifying equipment with high levels of automation is a plus.

Responsibilities

• Provide technical input to resolve process problems.
• Coach manufacturing personnel and increase their knowledge.
• Lead and implement continuous improvement initiatives.

Skills

Interpersonal skills

Problem-solving skills

Communication skills

Negotiation skills

Education

BS in Life Sciences or related field

Job description

Staff Process Specialist - Manufacturing

Responsibilities

• Provide technical input to resolve process problems both on and off the production suites.
• Coach manufacturing personnel to increase technical knowledge of critical process steps on the floor.
• Support manufacturing personnel in implementing improvements to the process or work systems in the suites.
• Support CAPA implementation on process‑related improvements.
• Support onsite educational programs to enhance technical competence of manufacturing personnel.
• Support all aspects of the manufacturing process according to approved protocols, regulation, and schedule.
• Support the technology transfer of the manufacturing process and liaise with the process science/technology transfer teams.
• Prepare reports by collecting, analyzing, and summarizing information and trends; review trends with the Process Science Group and present process trends.
• Lead investigations into process variances according to site procedures.
• Ensure that policies and procedures are effectively administered and comply with regulatory requirements.
• Communicate with supervisors on major problems regarding the process, schedules and materials.
• Guide and oversee validation activities involving manufacturing equipment and processes.
• Interface with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
• Work to the highest safety standards and support safety improvements requiring technical/engineering input.
• Track and trend relevant technical and business process metrics to ensure operations perform effectively and efficiently.
• Perform cGMP audits of the production area.
• Represent manufacturing during regulatory and client audits and respond to findings.
• Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, or other controlled documents as needed.
• Lead and implement continuous improvement initiatives.
• Act as system owner for defined manufacturing equipment and be involved in scheduling all non‑routine activities for that equipment.

Qualifications

• Knowledge of cGMP manufacturing environment and familiarity with formulation, aseptic filling, visual inspection (manual and automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products.
• Demonstrated strong interpersonal, cross‑cultural, communication, negotiation, and problem‑solving skills.
• Exhibits confidence, high emotional IQ, ingenuity, creativity, and resourcefulness.
• Ability to gain understanding from provided instructions and work toward established goals individually or as part of a team.
• Ability to understand and listen to team members and stakeholders’ needs while supporting a positive team environment.
• Technology transfer and equipment/process validation experience of aseptic, parenteral fill/finish operations preferred.
• Previous experience providing technical support preferred.
• Experience with lyophilization is a plus.
• Experience with operating and qualifying equipment with high levels of automation is a plus.

Experience

• Must hold a BS in Life Sciences or related field.
• Principal Process Specialist – 8 years of relevant cGMP manufacturing/engineering/scientific experience.
• Staff Process Specialist – 10 years of relevant cGMP manufacturing/engineering/scientific experience.
• Senior Staff Process Specialist – 12 years of relevant cGMP manufacturing/engineering/scientific experience.
• May consider experience in lieu of education or equivalent combination of education and experience.

Benefits

Salary Range (annually) $92,200.00 - $206,100.00.

Benefits may include health and wellness programs (medical, dental, vision, life and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves such as military and parental leave.

EEO Statement

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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.