Associate Director, Analytical Development and Operations, C
Company: Takeda Pharmaceuticals International GmbH
Location: Boston
Posted on: February 25, 2021
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Job Description:
The health and safety of our employees and candidates is very
important to us. Due to the current situation related to the
Coronavirus (COVID-19), we're leveraging our digital capabilities
to ensure we can continue to recruit top talent at Takeda. As your
application progresses, you may be asked to use one of our digital
tools to help you through your recruitment journey. If so, one of
our colleagues will explain how these tools will be used during the
recruitment process. Thank you. *Please be aware of an Identity
Theft Scheme targeting individuals seeking jobs with Takeda and
other employers. See below or here for more info. Associate
Director, Analytical Development and Operations, Cell Therapy
Takeda fosters a collaborative and stimulating work environment
filled with opportunity and the chance to make a difference in
people's lives. It is a workplace driven by integrity, one of
Takeda's long-held values that extends to both the patients we
serve and our employees who develop and deliver medicines. Across
our company, Takeda employees bring together diverse strengths that
together create a stronger whole. As one of the world's leading
biopharmaceutical companies, Takeda is committed to bringing Better
Health and a Brighter future to people worldwide. We aspire to
bring our leadership in translating science into life-changing
medicines to the next level, in our core focus areas; oncology,
gastroenterology, neuroscience, rare diseases, plasma-derived
therapies, and vaccines. The Greater Boston Area is headquarters to
many of our Global and US business units. We are a passionate team
doing important work that impacts patients' lives. If you are
driven to create better health and a brighter future, join us!
Success What makes a successful member of our team? Check out the
traits we're looking for and see if you have the right mix. Life at
Takeda A Global Top Employer Recognized for our culture and way of
working, we're one of only select companies to receive Top Global
Employer -- status for 2021. Associate Director, Analytical
Development and Operations, Cell Therapy Job ID R0022622 Date
posted 02/01/2021 Location Boston, Massachusetts Are you looking
for a patient-focused company that will inspire you and support
your career? If so, be empowered to take charge of your future at
Takeda. Join us as an Associate Director, Analytical Development
and Operations, Cell Therapy, in our Cambridge office. As an
Associate Director working on the Cell Therapy Analytics team, you
will be empowered to drive advanced analytical method development
and QC activities related to Cell therapy products. POSITION
OBJECTIVES: Accountable for the leadership of the Cell Therapy
analytical development team, including defining its vision,
strategy, execution, hiring, training, staff assignment, coaching,
mentoring and performance management. Accountable for analytical
development capabilities buildup and integrating analytical methods
into early stage clinical manufacturing, product release testing,
and product characterization. Responsible for the transfer of
analytical methods from/to CROs and/or monitoring the testing
and/or methods internal transfer globally. Accountable for
developing and executing Cell Therapy CMC strategies to enable and
deliver IND and BLA filings. Responsible for establishing operating
budgets and managing expenses within those budgets. Takeda's Cell
Therapy Analytics team is seeking an Associate Director to have
overall responsibility for leading and managing analytical methods
for cell therapy pipelines, which includes but not limited to
analytical methods development, qualification and tech-transfer;
working with CRO/CDMO for tech-transfer and product testing. The
ideal candidate will also assume a key leadership role in the
development of analytical strategies for cell therapy pipelines.--
POSITION ACCOUNTABILITIES: Provide strategic, technical and
scientific leadership to Cell Therapy analytical development team
Accountable for analytical capabilities buildup and team
management; Lead and manage analytical activities internal and
externally, execution and data analysis Review/approve technical
reports, controlled clinical manufacturing sample analysis
documents (e.g., analytical methods and associated protocols, SOPs,
etc.) and incorporate regulatory documents. Accountable for
developing and executing Cell Therapy CMC strategies to enable and
deliver IND and BLA filings. Collaborate closely with other key
line functions and communicates complex data/decisions within
department and cross functionally Responsible for integrating
scientific/technical efforts around cross-functional issues
EDUCATION, EXPERIENCE AND SKILLS: Advanced degree (PhD highly
desirable) in relevant scientific discipline (such as
Biotechnology, Immunology, Molecular Biology, Biochemistry,
Bioinformatics) with minimum 7 years of relevant industry
experiences. Excellence and successful track record in leadership,
people management and managing interfaces with other functions and
integrated teams. Proven track record and demonstrated deep
understanding of pharmaceutical drug development, program and
project development. Significant prior experience in driving method
development for cell and gene therapy products and Deep
understanding analytical platforms, e.g. flow, ELISA, PCR and cell
based assays; Prior experiences in GMP QC environment is a big
plus; Understanding of various cell and gene therapies, gene
editing technologies with previous experience in CAR T or CAR NK
products; Prior experience with IND, NDA or BLA desirable TRAVEL
REQUIREMENTS: May require approximately 15% travel. Check out where
you could be
working if you apply. Job Seekers: Protect yourself against
identity theft Please be aware there are instances of identity
thieves posting Takeda-branded jobs and posing as employees to
steal personal information. They visit job-related websites and
invite candidates to online chats. During the chat, they press job
seekers to provide bank account information and Social Security
numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited.
All rights reserved.
Keywords: Takeda Pharmaceuticals International GmbH, Boston , Associate Director, Analytical Development and Operations, C, Executive , Boston, Massachusetts
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