The Manufacturing Associate Lead is responsible for the execution of all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, this position may rewrite complex procedures or initiate new procedures as applicable. The Manufacturing Associate IV has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. The Manufacturing Associate Lead is expected to fully participate in both departmental projects and any quality working teams which may be applicable. The incumbent acts as a delegate to the supervisor and may conduct departmental activities in their absence. This position fully understands the regulations and may make recommendations according to their interpretations. All of the specific requirements presented in this job description are applicable to the functional area in which it resides.
Essential Duties and Responsibilities
- Support Cell Culture/Purification operations for the production of a bulk drug substance product.
- Prepare media and buffer solution.
- Clean, Set up, operate, and teardown of equipment such as tanks, filtration systems, carton assembler, bioreactors, and production lines.
- Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).
- Monitor and record critical process parameters.
- Complete relevant paperwork following GDP/GMP guidelines.
- Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.
- Manually clean portable equipment and small parts.
- Perform sampling using aseptic techniques.
- Participate on Continuous Improvement Teams.
- Receive and distribute supplies into production area as necessary.
- May perform other duties as assigned.
- Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations
- Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply
- Clean, Set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines, lyophilizers, etc.
- Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc.
- Receive and distribute supplies into the manufacturing areas.
- May perform other duties as assigned.
- Must be able to perform the qualifications of a Manufacturing Associate III.
- Technical Skills An expert with set up, maintenance, and break down. Expert with JDE and understand how to work within the system on all aspects relevant to Biologics Manufacturing. As well as be able to train junior employees, review and issue batch records.
- Troubleshooting Considered a technical expert on all processes. Able to troubleshoot effectively and train junior associates on troubleshooting techniques.
- Theoretical Knowledge - Strong knowledge background associated with areas they are performing. Able to train others on the theoretical basis of protein manufacturing.
- Written Communication - Able to draft complex DCRs and complete major NCR investigations. Drafts and owns significant ECR and CCRs.
- Interpersonal Communication - Strong communication skills. Able to effectively lead cross-functional meetings and effectively engage management.
- Presentation Skills Proactively looks for opportunities to educate group and external departments.
- Sphere of Influence Able to influence within the organization
- Leadership Able to provide leadership to the shift and within the department.
- Logistics - Able to direct a team of peers to procure items for multiple processes. Understands and proactively seeks to implement Kanban and other controls to ensure material availability.
- Planning Proactively removes barriers that would delay operations. Attends planning meeting as department representative and takes appropriate action items.
- Processing Capabilities - Demonstrated ability to assign roles during a product campaign.
- Project Performance - Consistently defines and leads improvement projects. Understands how to implement new technologies and has a solid understanding of Lean methodologies.
- Training - Mentors MA I III. Able to train on complex theoretical and technological concepts.
- Continuous Improvement - Demonstrated ability to facilitate or lead kaizen or continuous improvement teams.
- The position requires shift, weekend, and holiday work. Overtime may be required at times
- Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
- Demonstrated understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP).
- Ensure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately.
- Understand ergonomic relationship between people, equipment and working environment.
- Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.
- Must have the ability to navigate electronic mail systems and intranet for communication purposes.
Lead Role Responsibilities
- Drive a culture of excellence utilizing error free performance and right first time practices, including audits.
- Behave in a professional and ethical manner. Serve as interface between floor staff and management.
- Be present on the floor, provide training and technical oversight, when needed.
- Lead by example by demonstrating the Takeda Leadership Behaviors.
- Meet with outgoing and incoming shift lead/Management to assess schedule adherence and align on expectations for incoming shift activities.
- Facilitate shift change over by updating board and conducting meetings with latest schedule of manufacturing activities, provide process updates, and ensure shift notes are accurate and delays escalated.
- Disseminate information as needed to team members (e.g. awareness training, emergency or urgent work requests, non-routine sample requests or changes to operational procedures)
- Schedule and assign daily tasks, breaks and monitor execution of required tasks as set by shift supervisor. Be aware of staff training needs and assign daily tasks accordingly.
- May support cross functional teams
- Conduct documentation review, as needed
- Communicate to supervisor any concerns and feedback related to floor issues
- Support LDI-phase I-GEMBA to address housekeeping concerns
Serve as area department contact and back-up when Supervisor is not present or as needed. As the supervisor back-up, lead will be expected to support trouble shooting activities, contact support groups when external assistance is required and make decisions within experience and comfort level, elevating to area Manager when required.
Education and/or experience
Requires Bachelor s degree with a minimum of 3 years of manufacturing experience or AA degree with minimum of 7 years of related work experience. With demonstrated working knowledge of scientific principles. Engineering or Scientific degree preferred.
- Internal Candidates: The aforementioned requirements are preferred for internal candidates. They must demonstrate the proficiencies/qualifications in order to qualify for the position.
The overall physical exertion of this position requires medium to heavy work.
- May be required to sit between 1-2 hours in all Manufacturing areas.
- May be required to walk between 3-4 hours in Bulk and over 4 hours in the F/F and Suite A areas.
- May be required to stand for 3-4 hours in Bulk and Suite A and over 4 hours in F/F.
- May be required to bend at the neck/waist for up to 1 hour in Bulk, between 1-2 hours in Suite A and over 4 hours in the F/F areas.
- May be required to squat up to 1 hour in Bulk, and between 1-2 hours in Suite A and F/F.
- May be required to climb (use step stools and ladders) up to 1 hour in all Manufacturing areas.
- May be required to reach above/below the shoulder between 1-2 hours in Bulk and Suite A and between 3-4 hours in the F/F areas.
- May be required to kneel up to 1 hour in all Manufacturing areas.
- May be required to twist at the neck up to 1 hour in Bulk and Suite A and between 3-4 hours in the F/F area.
- May be required to twist at the waist up to 1 hour in Bulk and between 3-4 hours in the F/F and Suite A areas.
- May be required to lift up to 50lbs in the F/F area, up to 75lbs in Bulk and over 75lbs in the Suite A area. Lifts per shift are up to 14 times in Bulk and Suite A and up to 100 times in the F/F area.
- May be required to carry up to 25lbs in Bulk and Suite A and up to 50lbs in the F/F areas. Carry distance of up to 30ft in Bulk and Suite A and up to 6 feet in the F/F areas. Carries per shift are up to 6 times in Bulk, up to 14 times in Suite A and up to 100 times in the F/F areas.
- Requires repetitive use of both right and left hands and arms up to 3-4 hours in all Manufacturing areas.
- May require simple grasping up to 1 hour in Bulk and Suite A and between 3-4 hours in the F/F areas.
- May require power grasping up to 1 hour in Bulk and Suite A and over 4 hours in the F/F areas.
- May require fine manipulation up to 1 hour Bulk and Suite A and between 1-2 hours in the F/F areas.
- May require pushing/pulling with hands/arms between 1-2 hours in Bulk and Suite A and between 3-4 hours in the F/F areas.
- May require office work activities with hands/arms up to 1 hour in Bulk and between 1-2 hours in Suite A and the F/F areas.
- May be required to gown frequently and balance when gowning into clean areas.
- Will not be required to drive cars, trucks, forklifts or other equipment.
- May be required to work around moving equipment and machinery.
- Will not be required to walk on uneven ground.
- May be exposed to noise above 85 dBA in Bulk and Suite A. This may require hearing protection and other protective equipment to be worn.
- May work and have exposure to hot, cold, wet environment/conditions in all Manufacturing areas.
- May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
- May be required to work at heights above floor level.
- Will not be required to operate foot controls or repetitive foot movement.
- May require the use of special visual or auditory protective equipment in Bulk and F/F areas.
- May be required to work with biohazards such as: bloodborne pathogens, seage or medical waste in the F/F areas.
- May be required to drive to travel to other facilities, training sites, and off site meetings.
- May be required to work in confined areas. Will require entering a 2-8 degree Celsius & -60 degree Celsius freezer to store and retrieve materials and various chemicals in support of mfg such as IPA, 500ppm sodium hypochlorite in the F/F area.
- Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
- Will have interaction with other people.
- Pace may be fast and job completion demands may be high.
- This position requires shift, weekend and holiday work.
- Overtime may be required at times.
- May be required to work or be assigned to a different shift as needed.
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.