Head of Microbiology

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the Head of Microbiology in our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As the Head of Microbiology, you will be empowered to determine the strategy and direct the activities of Microbiology and Raw Materials & Utilities Laboratories at the Thousand Oaks Facility. This leader has the ultimate responsibility to ensure the implementation and on-going maintenance of prevention-based quality system including deviation management, CAPA, etc. The incumbent will be a member of the Quality Leadership Team (QLT) at the site and develop mid- and long-term strategy. Additionally, will partner up with the manufacturing Business Leaders to drive improvements in safety, quality, compliance, financial performance, employee development, customer satisfaction, and continuous improvement initiatives consistent with the Plant Strategic plan and Takeda values.

Essential Duties and Responsibilities

• Develops and deploys the Quality Systems (e.g. laboratory investigation, out of specification investigations, LIMS, assay validation, management review, CAPA, and process control) that ensure products conform to defined requirements.
• Understands and deploys processes to assure conformance to regulations.
• Actively leads or presents in regulatory inspections.
• Responsible for the Contamination Control Program for the Thousand Oaks site.
• Responsible for immediate escalation of issues that could impact product quality, safety and/or efficacy to Site Quality Head.
• Periodically reviews the suitability and effectiveness of the Quality System with Senior Management.
• Interacts frequently with all levels of internal management as well as across functional and business units.
• Manages interactions with customers and regulators concerning the quality of products, systems, and processes.
• Identifies and manages continuous improvement projects that may span multiple sections or departments with objective of achieving quality, reliability and cost improvements. Actively supports/directs strategies to continuously improve laboratory appearance, laboratory processes and results.
• Responsible for adherence to specification and procedures that have been established to ensure product quality in area of responsibility.
• Oversees the development and implementation of standards, methods, procedures and sampling for inspection testing and evaluating the precision, accuracy and reliability of the product.
• Develops 3 to 5 year strategy for the function.
• Develops operational budget and capital budget for Microbiology and Raw Materials & Utilities organization. Completes budget and adheres to budget/forecast. Continues to determine Value Improvement Projects (VIP) to lower operational costs and improve lab efficiency.
• Directs organization of 2-3 direct reports and approximately 20-25 indirect headcount. Manages overall coaching, training, development and succession plans for the team.
• Responsible to drive and support a strong quality culture at the site.

Qualifications

• In depth knowledge of the regulatory environment for manufacture of biological products. Includes strong knowledge of FDA, EMA, and ICH regulations and UISP, EP, and JP requirements.
• Strong drive for continuous improvement activities within the lab.
• Strong leadership skills and demonstrated success in managing a large team. Ability to build layers of succession within the organization and talent pipeline.
• Strong analytical problem-solving skills.
• Excellent verbal and written communication skills.
• Success working with multifunctional cross facility global teams.
• Excellent interpersonal/communication/influencing/negotiation skills required.
• Demonstrated problem solving skills.
• Demonstrate the Takeda Leadership Behaviors and Values. Utilizing the following four principals: Patient, Trust, Reputation and Business to make decisions.

Education and/or experience

• Bachelor's Degree in Chemistry, or biological science with 9-13 years of experience, or Master's Degree in Chemistry, or biological science with 7-11 years of experience.
• PhD in relevant scientific field with 4-8 years of management experience is ideal.

Physical Demands

• Must be able to lift, push, pull and carry up to 10 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

• Must be able to work in controlled 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 the manufacturing environment.
• Will work in a cold, wet environment
• Must be able to work multiple shifts, including weekends.
• Must be able to work overtime as required. (only for non-exempt positions)
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

This posting excludes CO applicants.

Locations

USA - CA - Thousand Oaks - Rancho Canejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time