Summary of Position
The Supervisor/Manager, Protein Purification Manufacturing is responsible for planning and driving the execution of manufacturing activities in the Protein Purification area of a cGMP manufacturing area. This position will forecast monthly and weekly activities, plan daily activities and ensure staff are focused on these activities. He/She will motivate the team and drive actions to ensure adherence to overall production schedule and lot releaseschedule while maintaining a high level of quality and compliance. This position may also require some hands on support with the manufacturing processes.
Responsibilities and Job Duties
- Manage a team of Manufacturing Associates in Protein Purification area who conduct purification operations including filtration, chromatography, titrations, and column packing and order and account for consumption of raw materials and components. Identify and clearly communicate expectations, schedule and monitor work progress, provide guidance and direction, evaluate results, and deliver timely feedback.
- Ensure that all work is performed in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements and assure that activities meet all quality standards for cGMP and other applicable regulatory agencies.
- Ensure all staff are adequately trained on all cGMP manufacturing operations and documentation.
- Ensure successful implementation of new products and processes into the facility, including batch record creation, SOP creation, change controls, new equipment procurement, and area changeover activities.
- Effectively troubleshoot production equipment and processing problems of varying scope with minimal supervision. Raise more complex problems or concerns to senior management for guidance and assistance.
- Provide continuous development for Manufacturing Associates through activities such as assignments and associated technical training programs. Lead by example, recognize and celebrate successes, and address performance and behavioral issues.
- Work on problems of advanced scope, potentially cross-functional, where analysis of situation or data requires a review of identifiable and unknown factors and make recommendations for resolution or change to avoid recurrence.
- Participate in and implement continuous improvement and operational excellence methods and tools to improve the overall efficiency of production operations.
- Schedule and coordinate activities with other departments such as Quality Assurance, Quality Control, Facilities, Materials Management, and Validation.
- May also perform the tasks and duties of the manufacturing associates.
Education & Experience
- High school diploma or equivalent and a minimum of 8 years of related experience in a cGMP and/or bioprocessing environment
- Associates degree in a related discipline and a minimum of 3 years of related experience in a cGMP and/or bioprocessing environment
- Previous supervisory experiencepreferred
- High school diploma or equivalent and a minimum of 15 years of related experience in a cGMP and/or bioprocessing environment
- Bachelor’s Degree in a related discipline and a minimum of 5 years of related experience in a cGMP and/or bioprocessing environment
- Minimum of 2 years of direct supervisory experience
Knowledge, Skills and Abilities
- Excellent interpersonal and leadership skills
- Ability to influence others without direct authority
- Excellent organizational skills and attention to detail
- Results driven with demonstrated successful outcomes
- Ability to resolve problems with work processes and people
- Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
- Ability to handle multiple priorities in a fast-paced environment
- Excellent written and verbal communications skills
- Basic knowledge of chemistry and high degree of comfort with arithmetic
- Proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)
Individual will manage a group of Manufacturing Associates
- Six Sigma training
- Ability to lead and document formal risk assessments
- Experience writing Regulatory documents (IND, BLA)