Manager, Formulation Manufacturing [Remote]

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How will you make an impact?

Successfully lead downstream departmental manufacturing resources to deliver on customer commitments and expectations. This means being responsible for the carrying out a variety of functions related to Downstream Biopharmaceutical Manufacturing including but are not limited to activities such as conducting large scale chromatography, viral inactivation, viral filtration, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance.  Ensure right the first time and on time delivery of protein purification processes to support clinical and commercial biologics manufacturing. Demands are to be met in accordance with established safety, quality, efficiency, and regulatory standards. Lead all aspects of all manufacturing resources including personnel and equipment. Operate cross functionally and collaborate with peers both within and outside of department. Successfully drive focused performance management and talent development of direct and in-direct reports. Demonstrating proactive leadership inside of the department and strategic delivery of company goals and a continuous improvement approach is also an expectation.

What will you do?

• Lead day to day operations to ensure departmental commitments and deliverables are achieved to meet company objectives. This involves resource oversight, planning, delegation, prioritization, collaboration, etc. for Manufacturing groups.

• Maintain open communication via one-on-one and team meetings, and assure supervisory files are kept up to date.

• Encourage and lead all aspects of a culture of compliance regarding Safety, Environmental, 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 and challenge processes, solve problems, initiate improvements, establish procedures, transfer new products or technologies, implement projects, etc.

• Responsible for working with the Senior Manager to mature area systems on an annual basis

• Conduct hiring, coordinate training, prepare and communicate staff evaluations. Develop a team that is highly respected, engaged and actively develop and train high potential candidates for the next generation of leaders.

• Be a role model. Exude optimism. Support company direction and officers. Be a supporter and an asset to your peers. Be a representative for Manufacturing on site and back up / delegate for the backup for the area Senior Manager as the need arises.

• Select, develop and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures.

How will you get here?

• 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.

Knowledge, Skills, Abilities

• 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.

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

Physical Requirements / Work Environment

• Be willing to wear a full gowning suit which includes: bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions or hair care products, etc.) Able to meet clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves

• Ability to lift minimum of 25 lbs independently

• Ability to stand for 80% of shift

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Other

Relocation assistance is not provided.

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.