Manager, Formulation Manufacturing

Thermo Fisher Scientific • Saint Louis, MO

6d • Onsite

About The Position

This role is responsible for leading downstream departmental manufacturing resources to meet customer commitments and expectations. The position involves overseeing various aspects of Downstream Biopharmaceutical Manufacturing, including large-scale chromatography, viral inactivation and filtration, ultrafiltration and diafiltration, and aseptic filling of bulk drug substance. The goal is to ensure the right-first-time and on-time delivery of protein purification processes for clinical and commercial biologics manufacturing, adhering to safety, quality, efficiency, and regulatory standards. The role also entails leading personnel and equipment, collaborating cross-functionally, and driving performance management and talent development.

Requirements

• Bachelor’s degree required (prefer STEM Degree)
• 5+ years of industry experience, preferably in a cGMP environment
• 3+ years of management (leadership and talent development) experience
• Demonstrated success with continuous improvement and a dedication to craftsmanship and putting quality first.
• Understanding of production processes and the biopharma production environment
• Excellent understanding of cGMP and other regulatory requirements in the operation of cleanrooms
• Understanding of cGMP quality systems (e.g. change control, deviations, investigations, risk assessments, driving GDP within all documentation and records).
• Strong leadership skills to influence and build effective teams, gain agreement via collaboration, and handle difficult situations with tact and diplomacy.
• Mechanical and technical ability/proficiency
• Analytical problem-solving skills.
• Excellent planning and organizational skills and the ability to efficiently handle multiple tasks, issues, projects.
• Unquestionable integrity, dedication to EH&S and accountable when making sure teams follow regulations and procedures.
• Organized, efficient, and results oriented
• Good people coaching and development skills
• Expert in oral and written communication (verbal and written in English), as well as social skills.
• Computer literate with Microsoft Office tools, including report writing and graphing.
• Must be legally authorized to work in the United States now and in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

• Quality and/or Financial software (SAP, eDMS, Trackwise, LIMS, etc.) skills a plus.

Responsibilities

• Lead day-to-day operations to ensure departmental commitments and deliverables are achieved.
• Provide resource oversight, planning, delegation, and prioritization for Manufacturing groups.
• Maintain open communication through one-on-one and team meetings.
• Assure supervisory files are kept up to date.
• Encourage and lead a culture of compliance regarding Safety, Environmental, and Quality standards as required by cGMPs, Health Authority regulations, government agencies, and company standards/policies.
• Support all site audits and inspections.
• Ensure adequate manufacturing resources are dedicated to correcting important or critical issues.
• Serve as a leader on departmental and site teams to improve processes, solve problems, initiate improvements, establish procedures, transfer new products or technologies, and implement projects.
• Work with the Senior Manager to mature area systems on an annual basis.
• Conduct hiring, coordinate training, and prepare/communicate staff evaluations.
• Develop a team that is highly respected, engaged, and actively develops high-potential candidates.
• Be a role model, exude optimism, and support company direction.
• Be a supporter and asset to peers.
• Represent Manufacturing on site and back up/delegate for the Senior Manager as needed.
• Select, develop, and evaluate staff to ensure efficient operation of the function.
• Work with and advise staff on administrative policies and procedures.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• A range of employee benefits
• Innovative, forward-thinking organization
• Outstanding career and development prospects
• Exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager