Senior Manager, Microbiology
Apply NowCompany: BioSpace
Location: Los Angeles, CA 90011
Description:
Job Details
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
This position is responsible for determining the strategy and directing the activities of Microbiology Laboratories at the Los Angeles 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.
Supports the Contamination Control Program for the Los Angeles and Van Nuys Sites.
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.
Develop and implement the digital strategy in the Microbiology Laboratories. This may include championing Digital 4.0 elements such as Robotics Process Automation, Predictive Analytics and Paperless Lab.
Leads activities related to the Lab Accelerator and Agile 4.0 initiatives; Ensures consistent implementation of 5S, Standard Work, and Visual Boards.
Provides expertise on and supports data integrity gap remediation and improvements in the Labs.
Develops 3 to 5 year strategy for the function.
Develops operational budget and capital budget for Microbiology 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 3-5 direct reports and approximately 30 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.
Education and/or experience
Typically requires bachelor's degree, preferably in science, engineering or other related technical field.
7+ years of related experience with 2+ years in a management role.
Bachelor's Degree in Chemistry or Biological Science is preferred.
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 and/or wet environment.
Must be able to work multiple shifts, including weekends.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - CA - Los Angeles
U.S. Base Salary Range:
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
LocationsUSA - CA - Los Angeles
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job Exempt
Yes
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
This position is responsible for determining the strategy and directing the activities of Microbiology Laboratories at the Los Angeles 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.
Supports the Contamination Control Program for the Los Angeles and Van Nuys Sites.
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.
Develop and implement the digital strategy in the Microbiology Laboratories. This may include championing Digital 4.0 elements such as Robotics Process Automation, Predictive Analytics and Paperless Lab.
Leads activities related to the Lab Accelerator and Agile 4.0 initiatives; Ensures consistent implementation of 5S, Standard Work, and Visual Boards.
Provides expertise on and supports data integrity gap remediation and improvements in the Labs.
Develops 3 to 5 year strategy for the function.
Develops operational budget and capital budget for Microbiology 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 3-5 direct reports and approximately 30 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.
Education and/or experience
Typically requires bachelor's degree, preferably in science, engineering or other related technical field.
7+ years of related experience with 2+ years in a management role.
Bachelor's Degree in Chemistry or Biological Science is preferred.
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 and/or wet environment.
Must be able to work multiple shifts, including weekends.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - CA - Los Angeles
U.S. Base Salary Range:
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
LocationsUSA - CA - Los Angeles
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job Exempt
Yes