Microbiological/Environmental Monitoring Manager and Investigator
Company: Takeda Pharmaceutical
Location: Lexington
Posted on: April 25, 2024
Job Description:
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionJob Title: Microbiological/Environmental
Monitoring Manager and InvestigatorLocation: Lexington, MAAbout the
role:Primary duties of this position include serving as a lead for
various technical aspects of the QC and Mass Bio Ops areas. You
will provide both subject matter expertise and technical leadership
on activities such as microbiological/environmental monitoring
issues, investigations, quality events, data analysis and trending,
key program oversight, and collaboration on several teams. You will
also help manage departmental and cross-functional teams
occasionally.You will report to The Associate Director of QC
Support.How you will contribute:
- Influence the organizational control of Quality Systems:
Create/monitor/author deviations, Out of Specification (OOS) and
Out of Trend (OOT) and unexpected events. Monitor GMP
investigations progress and support process to closure. Escalate
conflicts that arise.
- Provide microbiological subject matter expertise and
consultation to QC and the Mass Bio Ops organization.
- Establish microbiological standards to enable best practices
and ensure cGMP compliance across QC and Mass Bio Ops.
- Lead technical improvement initiatives related to
microbiological issues and contamination control.
- Manage investigations, deviations, change controls, and
improvement initiatives related to microbiological issues and
contamination investigation regarding impact to lot release for
commercial manufacturing. Includes being a subject matter expert
for and conducting comprehensive investigations to determine
potential product impact, identify cause, and implement corrective
and preventative actions observing established procedures and
timelines.
- Lead management and perform document change requests for risk
assessments, policies and method SOPs.
- Work with the Mass Bio Ops contamination control program and
community of practice.
- Regulatory inspection preparation, audit support, and
remediation across MBO network.
- Support enhancement of Tiered board system, including
development and monitoring of metrics intended to drive business
process improvements .
- Collaboration with peers to drive the alignment of the QC
teams' activities across the sites.
- Liaise and collaborate with key stakeholders (PIER,
Manufacturing Sciences, Quality Sciences, Analytical Development
and Center functions) as applicable.What you bring to Takeda:
- BS Degree in Science or Engineering with 8 years of relevant
experience
- Proven record of cross-functional technical leadership,
including, motivate, and lead technical rigor
- Knowledge of cGMP and other regulatory requirements related to
manufacturing of biologics and monoclonal antibodies.
- Strong technical skills and experience in commercial
biopharmaceutical Quality/Manufacturing in the areas of
microbiology, environmental monitoring, microbiological testing,
cell culture and/or purification, engineering or validation
- Experience leading cross functional teams
- Must possess knowledge of cGMP, commercial operations and root
cause analysis tools
- Excellent verbal and written communication skills, including
demonstrated ability to effectively present to senior management
and regulatory inspectors
- Foster environment of learning and continuous improvement
- Actively seeks ways to improve current systems and processes
related to own activities
- Systematically seeks and applies best practices for problem
solving and gap identification beyond one's comfort level. Expands
problem solving abilities by assimilating new effective
approaches.
- Understand Takeda's business, objectives and operations and how
own activities fit within the company strategyImportant
Considerations:
- At Takeda, our patients rely on us to deliver quality products.
As a result, we must follow strict rules in our manufacturing
facilities to ensure we are not endangering the quality of the
product. In this role, you may: Work in a controlled environment
requiring special gowning and wear protective clothing over the
head, face, hands, feet and body. This may include additional
hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail
polish and/or artificial fingernails while in the manufacturing
environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work
supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and
Celite that may require respiratory protection.
- Limited travel expected. Travel between sites within
Massachusetts is required.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.Work policy.Preference
will be given to candidates with a remote location near, and
availability to work during the working hours of, the corporate
office in Boston, Massachusetts.#GMSGQ - #ZR1 - #LI-MA1Takeda
Compensation and Benefits SummaryWe 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 - MA
- Lexington - BIO OPSU.S. Base Salary Range:$108,500.00 -
$170,500.00The 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-term incentives. 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 StatementTakeda 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 - MA - Lexington - BIO OPSBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Boston , Microbiological/Environmental Monitoring Manager and Investigator, Executive , Lexington, Massachusetts
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