Head, Analytical Development Biologics - Late Stage (Senior Director)
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 7, 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 DescriptionOBJECTIVES: -
- Lead and develop a team of managers and scientists and their
teams in the field of analytical development in the field of late
stage biologics
- Oversee and manage phase-appropriate analytical development for
clinical trial material efforts across three main areas: a)
Characterization and comparability, b) Method development of
methods for non-routine and release/stability use, c) Method
development for In-Process analytics across all required analytical
techniques (including but not limited to HPLC, mass spectrometry,
immunological and potency assays, ---)
- Contribute to product development from Pharmaceutical Sciences
to Commercialization by collaborating with multiple functions
within the Pharmaceutical Science organization to improve
analytical, process and product knowledge. Including transfer of
development assets to the commercial organization.
- Contribute to overall functional direction globally and
represent function within CMC/Pharmaceutical Science and across the
global Takeda organization.
- Implement and execute externalization activities with external
partners, facilitate development of execution plans for each, and
ensure completion of agreed upon activitiesACCOUNTABILITIES: -
- Direct and indirect supervisory responsibilities in analytical
areas for development of high-quality late stage biologics
therapeutics (complex proteins, ADCs, mAbs, engineered
mAbs---)
- Drive global late stage team to obtain scientific data; data
compilation and review; preparation and review of technical
reports, global regulatory filings, and other documentation;
project/CMC team representation/leadership; technical interactions
with internal partners and contract laboratories
- Collaborate with other functions in Pharmaceutical Sciences to
encourage strategic alignment and successful achievement of shared
goals
- Be well versed in all stages of analytical development and
understand the global regulatory trends for CMC activities, to
ensure robust and high-quality regulatory filings in all major
countries
- Develop, implement and execute a smart sourcing strategy
- Lead global CMC key initiatives and represent Pharmaceutical
Science to other cross functional stakeholder key initiatives
- Manage functional area budget and human resources to be within
required limits
- Drive continuous improvement in the technology, methodology and
business processes used to support analytical development,
characterization and associated operational and documentation
systems
- Strong knowledge of ICH and other regulatory guidelines
including Quality by Design
- Maintain an active understanding of the future trends of
medicine to build an organization adaptable for the future
- Inspire confidence in team members and lead the organization
culture, promoting a healthy and inclusive working environment
- Build future leadership while mentoring direct reports and
junior employeesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Master or PhD in chemistry, biology, pharmacy, or related
pharmaceutical science; at least 10 years relevant industry
experience including significant experience in analytical science,
cGMP compliance, CMC regulatory requirements in multiple analytical
development areas
- Leadership experience of teams including managers and
scientists. Development of team members to managers of scientific
analytical teams including individual contributors with an
exceptional commitment to science
- Direct experience in analytical development for biologics,
especially late stage assets, and ability to drive study completion
in a timely, sustainable, robust and cost-efficient manner
- Drive decision making within a cross-functional, cross-cultural
global team structure
- Knowledge and experience with product development and clinical
supply processes and product commercialization. Quality experience
is of advantage
- Experience in reviewing and approving analytical-related CMC
sections of IND/IMPD and BLA/MAA regulatory submissions.
Knowledgeable in European, Japanese, Chinese and US CMC regulatory
requirements for Biologics
- Develop, implement and execute a smart sourcing strategy
- Deep and broad knowledge of analytical chemistry of biologics
in support of drug substance and drug product release and stability
method development, raw material control, in process control, and
characterization
- Exceptional problem solving and troubleshooting skills related
to analytical methodology
- Proven working knowledge of current GMPs, ICH guidelines
including Quality by Design, other regulatory requirements, and
various quality system
- Proven knowledge, skills, and abilities with statistical
analysis (with emphasis on analytical testing applications).
- Knowledge of complex and state-of-the-art methodology for
biologics GMP method development and characterization
- Proven ability to work efficiently and effectively as a leader
of managers and scientists
- OPEX and CAPEX budget planning and controlling skills and
efficient resource planning
- Strong verbal, presentation, and written communication skills.
- Can concisely articulate and deliver effective presentations on
complex technical issues to non-technical audience.
- Ability to create collaborative and trusting relationships
internally and with external partners.
- Requires strong organizational skills and attention to detail
for composing and proofing materials, scheduling, establishing
priorities, and meeting deadlines.
- Other professional competencies include: building authentic
relationship, global and cross-boundary communication, excellence
in execution, courage to challenge, inspiring and motivating
othersTRAVEL REQUIREMENTS:
- Approximately 10-15% travel is required, including domestic and
international flights with overnight staysTakeda is proud in its
commitment of 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.Discover more at
takedajobs.comNo Phone Calls or Recruiters Please.#LI-KD1Takeda
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:Boston,
MAU.S. Base Salary Range:$205,100.00 - $322,300.00The 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.LocationsBoston, MAVienna,
AustriaWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
time
Keywords: Takeda Pharmaceutical, Salem , Head, Analytical Development Biologics - Late Stage (Senior Director), Executive , Boston, Massachusetts
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