Senior Director, Process Development

Employer
Lundbeck
Location
Bothell, WA, United States
Posted
Feb 25, 2021
Ref
1682
Hotbed
BioForest
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 Late-Stage Development and Production groups. 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!

Responsible for leading upstream and downstream development of biologics at Lundbeck . This individual will lead phase-appropriate process development efforts including optimization, technology transfer, scale-up and validation of manufacturing processes for all biologic programs. This role will be a key leader and contributor within the CMC organization at Lundbeck Seattle BioPharmaceuticals. The successful candidate will be an experienced, confident, technical leader with a proven track record in managing and leading biologic programs through development, including process characterization and validation in support of product licensure and commercialization. This position will also be responsible for managing resources and budget for the department. The candidate will work closely with senior leadership in Formulation Development & Drug Product, Analytical Development and Quality Control, and Bioanalytical to accomplish strategic objectives, as well as drive continuous improvement.

ESSENTIAL FUNCTIONS:
  • Lead upstream and downstream process development strategy and execution to provide robust, high-yielding, high-purity, efficient and scalable manufacturing processes.
  • Provide technical and scientific direction to CMOs and external laboratories to ensure project deadlines and performance standards are met
  • Ensure process knowledge is documented appropriately and sufficient to support efficient process transfers to CMO's and applicable Regulatory filings
  • Lead the development/optimization of scalable, efficient, and cost-effective drug substance manufacturing processes
  • Lead team members in implementing a design of experiments approach for laboratory work associated with initial process robustness and subsequent characterization studies
  • Responsible for functional area leadership in technical issue resolution with CMO partners
  • Partner with team members to support process validation activities and strategies including support of process risk assessments and control strategies throughout process validation
  • Oversee the preparation of technical reports, data summaries and CMC related documents required for regulatory submissions
  • Analyze and interpret results and methods, troubleshoot problems, generate solutions to problems and meet phase appropriate regulatory expectations for process development
  • Create and review technical documents, reports, and presentations for cross functional teams. Manage related SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices
  • Leverage prior knowledge, data and scientific innovation to accelerate speed and efficiency of early and late stage development programs
  • Lead platform development and support technology assessments with a goal toward innovation and maintaining the Seattle site as a state-of-the-art process development headquarters.
  • Effectively manages, mentors and develops full staff through team meetings, 1:1 interactions and professional development opportunities.


REQUIRED EDUCATION, EXPERIENCE and SKILLS:
  • Accredited Bachelors' degree with 15+ years of relevant biopharmaceutical industry experience with upstream or downstream process development for biologics
  • Expertise in process design and development of upstream and downstream manufacturing strategies that are informed by a thorough understanding of regulatory requirements
  • Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship
  • Proven leadership with successfully developing robust and efficient manufacturing processes capable of supporting clinical studies and scale-up to support commercial manufacturing demands
  • Ability to work/lead as part of a dynamic group that leverages a multi-disciplined team approach to executing and achieving departmental and corporate goals
  • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
  • Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
  • Ability to think outside of the box and challenge the status quo
  • Natural entrepreneurial spirit with unrelenting dedication to delivering results
  • Desire to work in a fast-paced, innovative environment
  • Natural collaborator who enjoys working on/leading cross-functional teams
  • Strong management experience and demonstrated success developing scientific teams and robust manufacturing process


PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
  • Accredited Bachelors' degree in engineering, chemistry, biological science or another relevant field with 15+ years of relevant biopharmaceutical industry experience with upstream or downstream process development for biologics
  • PhD with 15+ years of relevant biopharmaceutical industry experience with upstream or downstream process development for biologics
  • Experience with monoclonal antibodies


TRAVEL
  • Willingness/Ability to travel up to 10% domestically and internationally


Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time?

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 .

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Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind

Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.