Operations Manager

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:

Carlsbad, CA

At Microbial Manufacturing Services (MMS) we have the expertise and resources necessary to deliver on process development activities through commercial manufacturing, to enable our client's innovative use of plasmid-based therapeutics as critical raw materials and drug substance (DS). MMS is part of Thermo Fisher's Pharma Services Group (PSG) that includes Cell & Gene Therapy, and it is dedicated to support our customer's pursuit to develop new treatments for genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

The Manager of Operations will report to the Sr. Manager of Operations and will provide cross functional leadership, business acumen, and operational excellence focused on ensuring operational readiness and reliably meeting product delivery targets. You will lead and develop your group to ensure adherence to quality guidelines for GMP Manufacturing. You will partner across the site to implement robust business and manufacturing processes and support production planning, execution and timely disposition of products in a fast-paced, CDMO production environment. You will identify continuous improvement opportunities across the primary operational pillars of Safety, Quality, Delivery, Cost, and People (SQDCP).

What will you do?

• Ensure personnel safety for assigned areas and establish work practices in accordance with site and company EHS programs.
• Provide daily management of manufacturing activities for microbial produced products used as raw materials or Drug Substance (DS), ensuring compliance with global cGMP guidelines.
• Collaborate with Planners/Schedulers and Procurement/Logistics on operational readiness activities, including material resource planning, alternates evaluation, and supply risk management.
• Assist in evaluating and implementing short and long-term scheduling and resource modelling to meet business demands.
• Assist in evaluation of equipment, laboratory space and operational workflow in order to keep pace with increases and changes in production requirements relative to throughput, efficiency, and advances in technology.
• Maintain and evaluate metrics to drive for best in class for on time start, right first time and on time delivery to achieve the highest level of customer satisfaction.
• Work closely with management team to set and/or implement policies, procedures, and systems and to follow through with implementation.
• Partner with external and internal stakeholders to drive technical transfer of client processes into manufacturing including management of inventory, change controls, development / revision of batch records and procedures, and establish process and equipment training programs.
• Recruit and develop staff to execute department functions; ensure effective utilization of resources through strong people leadership including consistent performance
• Drive a culture of continuous improvement and Operational Excellence instilling ownership and accountability.
• Proactively identify, assess, and mitigate quality, raw materials, operational, and organizational risks; escalate key risks and issues.
• Ensure production rooms operate efficiently (schedule, material staging, environmental monitoring, and facilities cleaning, maintenance, calibration) and activities are appropriately documented.

How will you get here?

Education:

• Minimum required education: Bachelor's in Life Sciences, Engineering or related field is required.
• Master's degree preferred.

Experience:

• Minimum of 5 years' management experience in biopharmaceuticals manufacturing.
• Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).

Knowledge, Skills, and Abilities:

• Thorough knowledge of cGMPs and regulatory requirements.
• Large scale cGMP cell culture & purification experience, preferably in a CDMO; preferably bacterial fermentation.
• Strong planning, organization, and multitasking skills.
• Strong interpersonal and communication skills.
• Ability to make decisions and work with minimal to moderate supervision.
• Solid understanding of applicable regulatory requirements
• Familiarity with business and financial principles.
• Leading and supporting large teams
• Unquestionable integrity
• Managing multiple projects
• Problem solving and critical thinking.
• Strong interpersonal and communications skills; written and oral
• Strong working knowledge of Microsoft Office

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 global 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.

Compensation and Benefits

The salary range estimated for this position based in California is -.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards