Senior Scientist, Potency Assays
Company: Lundbeck
Location: Bothell
Posted on: May 6, 2024
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Job Description:
Do you want to join a team where the mission is meaningful, the
challenges are complex, and you can directly see the results of
your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP),
located in Bothell, Washington, is the Process Development Center
of Excellence for Biologics within the global Lundbeck CMC
organization. Since integrating into Lundbeck in October 2019,
Lu-SBP has supported commercial launch of Lundbeck's first biologic
product (Vyepti) and advancement of a growing biologics pipeline in
collaboration with our Copenhagen-based Process Science &
Validation Team.The Lu-SBP team leads and supports the development
of new product candidates from cell line development through
commercial validation of Drug Substance and Drug Product
manufacturing processes. Join us on our journey of progress &
innovation dedicated to addressing the vast unmet medical needs
associated with brain disease!
Lundbeck Biopharmaceuticals is seeking a highly motivated and
experienced individual to lead the Potency Assay group supporting
the development of novel therapeutic antibody programs with a focus
on methods to determine the potency of drug product for early
through late-stage clinical development programs.
The successful candidate will have a thorough understanding of cell
biology, biochemistry and knowledge of binding and immunoassays as
well as demonstrated leadership in developing cell-based potency
assays as well as binding/immunoassays. Responsibilities include a
primary role in defining, developing and optimizing new potency
assays and then supporting transfer to QC, including supporting QC
(as needed) with method transfers, qualifications and validations
and ultimately serving in a Subject Matter Expert role. Key to the
position is a thorough understanding of the regulatory and industry
standards that are required for potency methods that will
ultimately contribute to our registration packages. This role will
interact with Lundbeck Seattle Upstream, Downstream, Formulation,
and Quality Control groups so strong interpersonal skills will be
beneficial.
ESSENTIAL FUNCTIONS
Develop strategy for potency assays including justification for
design of assay and link to mechanism of action (MOA)
Develop, optimize and qualify potency methods (including cell-based
bioassay and ligand binding potency assays) that are intended for
lot release, stability-testing, product characterization, reference
standard qualification and comparability evaluation
Provide scientific leadership of staff in the Potency Assay group
with responsibility for potency methods for all development
programs (from early to late phase clinical development)
Author and review SOPs, development reports, and technical
reports
In partnership with QC, serve as the Subject Matter Expert (SME) in
the transfer of analytical methods from Lundbeck to GMP contract
labs/contract manufacturing organizations (CMOs)
Collaborate with QC to ensure successful method validation at
contract labs/CMOs; support investigations and lead troubleshooting
efforts as required
Prepare and qualify cell banks required for cell-based bioassays;
partner with QC to establish and qualify GMP analytical cell banks
at contract labs (suitable for use in GMP testing)
Oversee routine analytical testing and coordinate study support
across Quality Control (QC) and Process Development (PD) groups
Oversee routine maintenance of laboratory equipment and the
critical reagent program for potency methods
Develop and maintain processes for tracking assay performance
Identify and implement new technologies and innovative approaches
to measure the potency of our pipeline molecules
Present results and development information to cross functional
teams and other internal functions and represent the Potency team
as needed
Assist in the preparation of CMC regulatory submissions including
authoring and/or review
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
Accredited Ph.D., M.S. or B.S. in cell biology, molecular biology,
biochemistry or related field with 5+ years of relevant experience
for Ph.D. level, 10+ years of relevant experience for M.S or 12+
years of relevant experiencefor a B.S. level
Strong technical skills including demonstrated experience in
leading the development and optimization of potency assays
(including cell-based bioassays) with solid understanding of
requirements for transfer and validation of the method for use by
QC
In depth knowledge of cGMP regulations, compendial requirements and
regulatory requirements for potency assays
Ability to translate the mechanism of action into a cell-based
assay
Demonstrated ability to effectively and independently manage
laboratory work and data, including proficiency in data and
statistical analyses
Experience with current statistical approaches to evaluating
potency data including parallel line analysis, determination of
relative potency and USP chapters on Bioassay
Highly competent in common software and data analysis packages
Excellent communication (written and verbal), technical and
organizational skills
Critical thinking, troubleshooting and attention to detail
Strong interpersonal skills and the ability to work in a
multi-disciplinary team environment
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
Experience leading and developing a team
Experience in supporting regulatory submissions including
authoring/review and responding to regulatory questions
TRAVEL:
Willingness/Ability to travel up to 10% domestically and/or
internationally.
The range displayed is specifically for those potential hires who
will work or reside in the state of Washington, if selected for
this role, and may vary based on various factors such as the
candidate's qualifications, skills, competencies and proficiency
for the role. Salary Pay Range: $140,000 - $170,000 and eligibility
for a 15% bonus target based on company and individual performance,
and eligibility to participate in the company's long-term incentive
plan. Additional benefits for this position include flexible paid
time off (PTO), health benefits to include Medical, Dental and
Vision and company match 401k. Additional benefits information can
be found on our .#LI-LM1
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help
employees live well and protect their health, family, and everyday
life. Information regarding our benefit offering can be found on
the .
Lundbeck is committed to working with and providing reasonable
accommodations to disabled veterans and other individuals with
disabilities during our employment application process. If, because
of a disability, you need a reasonable accommodation for any part
of the application process, please visit the .
Lundbeck is proud to be an equal opportunity workplace and is an
affirmative action employer. We are committed to equal employment
opportunity regardless of race, color, religion, sex, sexual
orientation, gender identity, age, national origin, disability,
protected veteran status, and any other characteristic protected by
law, rule, or regulation. Lundbeck participates in .
Keywords: Lundbeck, Renton , Senior Scientist, Potency Assays, Other , Bothell, Washington
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