(General purpose of this position)

Provides direction and leadership to the Company's operations with oversight of Aseptic Manufacturing (formulation and filling) operations. This position works closely with all levels of Operations (Manufacturing and Finishing), Quality Assurance, Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.

ESSENTIAL DUTIES & RESPONSIBILITIES (Primary duties performed, either unassisted or with reasonable accommodation. Not meant to be an all-inclusive list nor prevent other duties from being assigned as necessary.)

  • Provide leadership to Aseptic Manufacturing Associates of various levels. Responsibilities include hiring, managing, motivating, coaching and mentoring.

  • Ensure oversight of Aseptic Manufacturing operations across all shifts, including weekend support as needed.

  • Completion of internal batch record review.

  • Client support / interaction related to these processes.

  • Assist with the authoring and implementation of manufacturing procedures and batch records.

  • Lead routine manufacturing activities; including day to day scheduling and raw

    materials/consumables management.

  • Provide leadership when performing component and equipment preparation, bulk drug formulation,

    and aseptic filling duties.

  • Accurately document data and complete batch records as needed.

  • Successfully complete facility’s gowning and media fill qualification program.

  • Perform and train other employees in various manufacturing tasks, including, but not limited to:

    Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability,

    and Sterile Filling.

  • Operate and assist with the maintenance of production equipment.

  • Perform duties in cleanroom areas and help to maintain those areas.

  • Ensure personnel are trained on all applicable procedures and master batch records prior to


  • Initiate revisions to cGMP procedures, and master batch records.

  • Assist in the scheduling and performance of routine maintenance and calibration of production


  • Participate in client communications, including problem solving, schedule development, and project

    status updates.

  • Interface with auditors, including client representatives and regulatory agencies.

  • Perform Manufacturing review and approval of cGMP documentation in support of continuous

    improvements, including:

o Procedures

o Master Batch Records
o Standard Work Instructions

o Risk Assessment Reports

o Training Curricula

  • Support Agency, customer and vendor audits as needed.

  • Exhibit professional behavior with both internal/external business associates that reflects positively on

    the company and is consistent with the company's policies and practices.

  • Perform all other tasks, projects, and duties as assigned.

EDUCATION, PRIOR EXPERIENCE, AND TRAINING (Minimum education, experience, licenses/certificates normally required to perform duties of this position.)

  • At least 2 years of prior management / leadership experience required.

  • Prior experience interacting with regulatory authorities is preferred.

    The level of knowledge required to successfully perform these duties is normally acquired through completion of a Bachelor’s Degree in Life Sciences or a related field and/or a minimum of 4-6+ years related work experience.

DESIRED SKILLS AND ABILITIES (Minimum technical and communication skill levels normally required to perform duties of this position.)

  • A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required; experience and expertise in aseptic manufacturing of regulated products is preferred.

  • Ability to interpret and relate Quality standards for implementation and review.

  • Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech

    manufacturing environment.

  • Ability to portray an appropriate level of integrity and professionalism at all times.

  • Ability to communicate effectively with management, staff, regulators and client representatives, in

    both written and verbal forms.

  • Ability to complete tasks accurately and according to established timelines.

  • Demonstrated management ability with a proven track record of leading teams to meet objectives.

  • Ability to make sound decisions about scheduling, allocation of resources and managing priorities.

  • Proficiency in both written and verbal communication and presentations

  • Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused,

    high-pressure entrepreneurial environment.

  • Results oriented and efficient.

  • Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.

  • Ability to work closely with a diverse customer and employee base (internally and externally).

  • Ability to work well in a cross-functional team environment.

  • Must have proficient computer skills in Microsoft Word, Excel and Outlook.

WORKING CONDITIONS & PHYSICAL DEMANDS (Typical working conditions associated with this type of work and environmental hazards, if any. The physical effort generally associated with this position.)

INTERNAL Work is normally performed in a climate-controlled office where exposure to conditions of extreme temperature, poor ventilation, fumes and gases is very limited. Noise level is moderate and includes sounds of office equipment. No known environmental hazards are encountered in normal performance of job duties.

EXTERNAL Work requires limited travel to regional offices and events.

GENERAL Work involves standing and walking for brief periods of time, but most duties are performed from seated position. Work may include occasional pushing, pulling or carrying objects weighing up to 20 pounds such as boxes of files. Work normally requires finger dexterity and eye-hand coordination to operate computer keyboard at moderate skill level.

The above description is a broad overview of this position and not all duties may be clearly pre-defined. From time-to-time, various projects may require more or less attention than described. If it is decided in the future that some tasks are better served in another department, by outsourcing, or due to technological developments, these duties may be subject to revision. In any event, this job description is in no way considered a contract of employment or an altering of the employment at-will relationship.

Job Type
Full-Time Regular
Grand Rapids MI