Sr Manager, Manufacturing

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This position is based in Austin, TX, and will support to the Genetic Sciences Division (GSD).

Discover Impactful Work:

You will provide leadership and scientific and technical expertise for qPCR and sample prep reagent manufacturing activities for the GSD and BID divisions at the Austin, Texas site.  You will identify and implement select improvement projects to production processes, methods and controls, including scope development, justification and execution as well as potential capital investment analysis.  You are an operations leader responsible for maintaining ISO 13485 and USDA compliance and for operating within project and department budgets. You serve as the leader of two biotech manufacturing and quality control teams, including bulk formulation, filling, and packaging roles, and indirect leadership of several supporting functions.  You are responsible for hiring, training, goal setting and performance evaluation of leaders within the team. You will work closely with all departments and the appropriate project teams to assist in project planning and timeline development. You will follow up-to-date technical, regulatory and quality principles and ensures safe environmental and working conditions in the manufacturing facilities.

A Day in the Life:

• Oversee operations by leading day-to-day manufacturing activities for qPCR and sample prep reagent manufacturing, including capacity planning and budget management.
• Manage team of supervisors and scientists. Hire and develop employees within the department. Provide feedback and coaching and take necessary disciplinary actions.
• Support establishment and/or enhancement of operational goals and metric, including STRAP, AOP, and HRR, and review outcomes in Quarterly Business Reviews.
• Serve as backup and successor for Operations Director in audits, tours, and tier meetings.
• Seek the highest level of compliance, efficiency, and robustness of specified manufacturing and in-process testing methodologies.
• Lead efforts around bringing in new technology, equipment, methodologies and associated validations.
• Train, mentor, and coordinate operations team members to meet or exceed departmental standards and key performance indicators.
• Provide manufacturing leadership, guidance and support throughout the organization. Work cross functionally and ensure good communication across the network.
• Manage process improvements utilizing PPI, 5S, Lean, and Six Sigma methodologies and work proactively with the team and internal customers to implement opportunities for continuous improvement.
• Support internal, external and regulatory inspections as needed. Serve as primary operations manufacturing contact for regulatory inspections and/or client audits.
• Meet production, quality, financial, staffing, and EHS goals and objectives, including but not limited to productivity, cost reduction, backorder, inventory, training, CAPA closure rates, etc.
• Direct and control the activities of multiple projects and personnel.
• Manage problem resolution, CAPA, and deviations via Trackwise.

Keys to Success:

Education

• Bachelor's degree in biological sciences, chemistry, engineering, or related field required. Master's Degree preferred; PhD is a plus.

Experience:

• 10+ years meaningful experience in a manufacturing position within the biological and/or pharmaceutical industry.
• 7+ years of leadership/management in a ISO 13485 or USDA-regulated environment is helpful.
• One or more advanced business, Six Sigma, supply chain, and project management degrees or certifications, e.g. MBA, CSSBB, CPIM, and PMP, is highly preferred.

Knowledge, Skills, Abilities

• Understanding of qPCR and sample prep methodologies is required; knowledge of quality analysis a plus.
• Experience with ISO9001, ISO13485, and USDA regulatory requirements.
• Experience with writing deviations, investigations and OOS required; experience with Root Cause Analysis a plus.
• Consistent record in driving continuous improvement.
• Requires interpersonal skills and the ability to lead and work cross functionally with teams.
• Strong organizational skills; ability to prioritize and lead through complex processes/projects including new product introductions.
• Ability to effectively present information to employees, top management, and public groups.
• Ability to use software and customized programs to meet business needs; familiarity with SAP and other business software a plus.
• Ability to write/review reports, business correspondence and standard operating procedures.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.