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Head of Microbiology
This position is responsible to manage, plan, organize, direct and evaluate all activities and staff of the Microbiology Department in the Quality Control Laboratory to ensure the safety and reliability of Takeda products, and to comply with Quality and Regulatory requirements. Work closely with manufacturing and product support teams to ensure product safety through Environmental Monitoring and Testing of Raw Materials, Critical Systems, In-Process Intermediates and Finished Drug Products. This position will support Quality Control Initiatives to drive improvements in safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant Strategic Plan. This position will make critical decisions to disposition raw materials, in-process and finished product testing results for release in a timely manner. Identify potential risks associated with laboratory operations and lead teams to resolve lab issues. Serve as a representative for the Quality Laboratory during Regulatory Inspections and Customer Audits. Responsible for leading troubleshooting activities for assays issues. Supports regulatory filings, submission review and data analysis.
Essential Duties and Responsibilities:
- Develops and deploys the Laboratory 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.
- Interacts frequently with all levels of internal and external management with frequent cross functional and network communication.
- Support network initiatives and community of practice (CoP) operating mechanisms.
- Manages interactions with customers and regulators concerning the testing and quality of products, systems and processes.
- Identifies and manages 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.
- 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 test methods to ensure test results meet defined criteria.
- Develops operational budget and capital budget for Microbiology organization. Completes budget and adheres to budget/ forecast. Continues to determine Value Improvement Projects (VIPs) to lower operational costs and improve lab efficiency and operation.
- Provide Microbiology group long term objectives, general policies and management guidance based on business directions and goals.
- 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. Prepare the department for both internal and external authorities. Serve as a Quality representative for the lab and interface with investigators and customers.
- Work closely with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, generate cost savings, and provide new product support. Responsible for leading and / or supporting complex investigations and trending laboratory results.
- Manage and improve operating mechanisms to ensure that non-conformances (OOLs, OOSs, and CAPAs) are completed in an effective and timely manner.
- Support the laboratory responsibility for annual product review to ensure effective and timely completion of responsibilities.
- Responsible for guidance on creation, changing and issuance of lab related documents.
- Assure a safe and non-discriminatory working environment for employees.
- Develops and manages operating budget for lab/ teams.
- Ensure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and ensure employees have development plans. Mentor and develop strong team.
- Interacts frequently with internal subordinate superiors, functional per and senior groups.
- Identifies and manages continuous improvement project with objective of achieving quality, reliability and cost improvements. Drive continuous improvement understanding to all laboratory levels.
- Responsible for the process of evaluating new technology for the lab and subsequent validation.
- Hire and retain great talent; develop, coach and provide challenging work for team members; support the career development of their employees both within their current positon as well in situations where employees move on to different roles within the Shire organization; aggressively manage performance and differentiate compensation and development; plan for future talent needs; improve performance of individuals and teams.
- Demonstrates the Takeda Leadership Behaviors and values. Also, makes decisions using the PTRB (Patient, Trust, Reputation & Business) lens.
- In depth knowledge of the regulatory environment for manufacture of biological products. Includes strong knowledge of FDA, EMA, and ICH regulations and USP, 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.
- Knowledgeable about Quality Laboratory operations and government regulations pertaining to pharmaceutical manufacturing labs. (Strong emphasis and experience in Microbiology).
- Ability to manage complex projects, resolve complex issues, critical problem solving.
- Possess excellent supervisory and interpersonal skills and be able to communicate with all level personnel and regulatory authorities.
- Should have advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP. Strong leadership, project and people management skills, and ability to make critical decisions. Strong understanding of the Biopharmaceutical business and/or industry.
Education and/or experience:
- Typically requires bachelor's degree in chemistry, biological science or other related technical field; 8+ years of related experience with 3+ in a management role.
- Must be able to lift, push, pull and carry up to 15 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- 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 and some clean room and cool/hot storage conditions.
- Must be able to work multiple shifts, including weekends and overtime.
- May be required to work in a confined area.
- 5% Travel.
Location and Salary Information: This post excludes CO applicants
EEO Verbiage for US Reqs
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.