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Manager of Quality Control Labs - Biochemistry (Head of MI&S)

Location
Los Angeles, California
Posted
22 Sep 2022

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Job Description

About the role:

  • You will lead the Method Introduction and Support team within the QC Biochemistry department.
  • You will report to the Head of Quality Control Laboratories and support Quality Control programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant Strategy.
  • You will make important decisions to support lab operations, business continuity and continuous improvement.
  • Support the release of materials & finished product promptly, address and resolve assay operational issues during normal and off-shift hours, identify potential risks associated with laboratory operations and lead teams to resolve lab testing challenges.
  • You will also serve as a representative for the Quality Laboratory during Regulatory Inspections and Customer Audits.
  • The preferred candidate will have a PhD in Bioengineering, Biochemistry or Biological Sciences.

How you will contribute:

  • Develop the Method Introduction and Support (MI&S) team to improve method reliability and lead operation efficiencies.
  • Oversee analytical method transfer (to the QC labs) and validation to ensure method robustness and suitability for intent of use.
  • Lead rapid response investigations, working with manufacturing teams, QC Labs and partners that directly affect business continuity.
  • Guide projects and CI programs to improve quality, efficiency, and cost savings.
  • Support complex investigations and data review/ trending.
  • Oversee lab standards and controls program to ensure qualification and availability of reference materials.
  • Support QC labs to ensure internal turnaround times (TATs)/schedule adherence are met.
  • Ensure compliance with testing procedures, specifications and company policies.
  • Develop enhanced cross-training program for all direct reports to enhance primary competency.
  • Recruit and develop great talent by making appropriate staffing recommendations and developmental plans/appraisals, improving individual performance and that of the team.
  • Coach and provide challenging work for team members, support their career development both within their current position and in situations where employees move on to different roles within the Takeda organization.
  • Manage performance and differentiate compensation based on individual contributions.
  • Develop strategy for future talent needs based on changes to our organization and new operational challenges.
  • Assure a safe and non-discriminatory working environment for employees.
  • Prepare the department for both internal and external authorities, serving as a quality representative for the lab.
  • Manage continuous improvement projects with objective of achieving quality and cost improvements.
  • Help manage operating budget as it pertains to specific responsibilities.
  • Ensure adherence to all environmental, health and safety procedures and promote a positive, safety-first culture.
  • Understand and deploy processes to assure conformance to regulations. You will also lead and present in regulatory inspections.
  • Work with all levels of internal and external management with frequent network communication.
  • Support network programs and community of practice (CoP) operating mechanisms.
  • Manage continuous improvement projects that may span multiple sections or departments with the objective of achieving Quality Lab excellence/Lab House, instrument reliability, sample/assay invalid reduction and overall laboratory cost improvements.
  • Support and direct strategies to improve laboratory appearance, laboratory processes and results.
  • Manage adherence to specification and procedures that have been established to ensure product Quality.
  • Oversee the implementation of standards, methods, procedures and evaluating the accuracy of the test methods to ensure test results meet defined criteria.
  • Provide Quality Laboratory management guidance to policies based on business directions and goals.
  • Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines); develop policies to implement these requirements for laboratory operation.
  • Ensure compliance with testing procedures, specifications and company policies.
  • Work with manufacturing teams in proactive functions that impact production, improve quality, increase efficiency, produce cost savings, and provide new product support. Lead complex investigations and trending laboratory results.
  • Manage guidance on creation, changing and issuance of lab related documents.
  • Assure a safe and non-discriminatory working environment for employees.
  • Ensure employees are trained and audited. Make appropriate staffing recommendations. Evaluate performance through performance appraisals and ensure employees have development plans and mentor your team.

What you bring to Takeda:

  • In-depth knowledge of the regulatory environment for manufacture of biological products. Includes knowledge of FDA, EMA, and ICH regulations and USP, EP and JP requirements.
  • Drive for continuous improvement activities within the lab.
  • Expertise in managing a large team and build layers of succession within the organization and talent pipeline.
  • Success working with multifunctional cross facility global teams.
  • Knowledgeable about Quality Laboratory operations and government regulations in pharmaceutical manufacturing labs. (Emphasis and experience in analytical methods).
  • Manage complex projects and resolve complex issues.
  • Advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP. Experience with the Biopharmaceutical industry.
  • Typically requires bachelors' degree in science, engineering or other related technical field. 6+ years of related experience with 1+ years as a supervisor experience for supervisory roles.
  • Must be able to lift, push, pull and carry up to 25 lbs.
  • In general, you will have a combination of sedentary work and walking around observing conditions in the facility.
  • Will work in controlled environments requiring special gowning. Will 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 support multiple shifts, including weekends and overtime.
  • May be required to work in a confined area.
  • 5% Travel.

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • 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 and company match of charitable contributions
  • Family Planning Support
  • Professional training and development opportunities
  • Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Location and Salary Information: This post excludes CO applicants

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Details

  • Job Reference: 718832307-2
  • Date Posted: 22 September 2022
  • Recruiter: Takeda Pharmaceutical
  • Location: Los Angeles, California
  • Salary: On Application