As part of Brammer s Cambridge Gene Therapy Site s manufacturing organization, the Manufacturing Manager-Bulk Drug Substance is responsible for leading the manufacturing team through production campaigns, owning the production suites and be accountable for schedule adherence. The Manufacturing Manager-Bulk Drug Substance reports into the head of manufacturing. He/she provides the cross functional leadership, operations acumen, and results focus to reliably meet timelines and due dates. This position requires an individual capable of partnering across the site to ensure sharing of best practices and learning opportunities, building robust business processes to drive sustainable performance and support the release of product in a fast-paced production environment.
- Ensure safety of manufacturing area and work practices in partnership with site EHS standards.
- Provide leadership, guidance, and direction to staff in alignment cGMP requirements and site directives.
- Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
- Proactively identify and escalate key risks and issues to manufacturing line and manufacturing leadership team. Organize and lead ad hoc cross functional teams to manage investigations and implementation of changes.
- Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
- Ensure high levels of communication with team, support resources and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
- Partner with technical leadership, program management and clients to implement product / process improvements; participates and/or may lead cross functional projects. Acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
Work Hours: Monday through Friday, 8:00 AM to 5:00 PM. Requires overtime to work evenings, weekends or holidays, as required to meet project timelines.
Thermo Fisher offers an attractive benefit package to all full time employees which includes; medical, dental, and vision coverage, company paid Disability and Life Insurance benefits, and a 401(k) Plan with a generous company match. All full time employees are also provided with paid time off, paid company holidays, and an incentive bonus plan.
Thermo Fisher is an Equal Opportunity Employer and participates in eVerify.
- Exhibits strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
- Provides effective written or verbal communication to peers, manufacturing staff, and area management within their operational group.
- Proficient at public speaking, teaching, facilitating to peers, manufacturing staff, and area management within their operational group.
- Recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to manufacturing or area management.
Education and Qualifications:
- Bachelor's degree and 9-11 years of related work experience or Master s degree and 6-8 years of work experience. Minimum of 5 years in management / leadership positions. Preferred experience working in 2 or more functional areas.
- Minimum of 3 years leading cGMP operations teams in fast paced production environment.
- Demonstrated ability to manage cross-functional teams and collaborate across the business.
- Strong analytical and problem solving skills; great attention to detail and excellent decision making process.
- Expertise in managing small and medium technical and/or capital projects.
- Demonstrated ability to present ideas persuasively and negotiate effectively.
- Excellent written and oral communication skills both internal and external.
While performing the duties of this job, the employee:
- Ability to function in a dynamic environment and balance multiple priorities simultaneously.
- Ability to learn new software and tools quickly.
- Ability to make decisions and work with minimal to moderate supervision.
- Ability to aseptically gown and/or sterile gown as needed.
- While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.
Associated topics: fertilize, forklift, fork lift, inventory, manage, mow, production management, prune, ship, watering