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 site.#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 U.S. career site.

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 U.S. career site.

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 E-Verify.