Senior Scientist II, Process Development

Allergan; Greenlawn (NY); On-site; USD 80,000 - 150,000; Full time

Job summary

An established industry player is seeking a CMC purification development scientist to join their innovative Biologics CMC Development team. This role focuses on developing robust processes for drug substance GMP production, enabling human clinical studies. Ideal candidates will thrive in a collaborative lab environment, leveraging their expertise in chromatography and virus clearance studies. With a commitment to advancing biologic therapies, this position offers an exciting opportunity to contribute to the development of novel oncology drugs and make a significant impact in the field of medicine.

Benefits

Paid time off

Medical, dental, and vision insurance

401(k) plan

Short-term incentive programs

Long-term incentive programs

Qualifications

• 12+ years of experience in CMC purification process development.
• Proven expertise in chromatography and virus clearance studies.
• Strong understanding of biochemistry and bioprocess engineering.

Responsibilities

• Develop and optimize purification processes for biologics candidates.
• Transfer processes to GMP manufacturing for clinical material production.
• Mentor and supervise team members in lab-based functions.

Skills

CMC purification process development

Chromatography separations

Analytical techniques (HPLC, ELISA)

Virus clearance studies

Technical writing

Collaboration

Attention to detail

Education

Degree in Chemical Engineering, Biochemistry, Chemistry or related field

Tools

AKTA chromatographic instruments

Microsoft Office

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Biologics CMC Development team at AbbVie has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing biologic therapies, such as monoclonal antibodies, bi-specifics and novel modalities, to human clinical studies and eventual licensure.This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs.

As one of CMC purification development scientist, you will apply your strong expertise in CMC purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. You will be responsible for all aspects of CMC purification program deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams.

This position is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in an onsite, highly collaborative lab environment with face-to-face cross-functional interactions between scientists.

Responsibilities include:

• Development, optimize, and scale-up purification processes for biologics candidates to support early and late stage development
• Demonstrate the ability to resolve key project or process hurdles by effectively utilizing available information, technical expertise, cross-functional collaboration and scientific literature
• Transfer processes to GMP manufacturing for clinical material production
• Work with contract labs and carry out viral clearance studies
• Conceive and evaluate novel, advanced bioprocess technologies and workflow methodologies that are in line with the group and company’s strategy
• Publish research in peer-reviewed journals and present work at scientific conferences
• Proactively seek out new information in the literature or through internal/external collaborations and incorporate the knowledge to address individual program needs as well as into platform project strategy
• Seize opportunities to pursue project relevant leads that are in line with the group’s strategy
• Maintain a high level of productivity in the lab by individual contributions and through mentorship or direct supervision

• Author technical publications, reports, presentations, and regulatory filings
• Work efficiently and collaboratively toward setting program specific functional and cross-functional project timelines and goals
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GxP compliance, where applicable
• Participate on cross-functional project teams
• May mentor/supervise a team; guide and evaluate the performance of those individuals; accountable for the effective performance of the team/individuals

Qualifications

• Degree in Chemical Engineering, Biochemistry, Chemistry or other sciences with BS or equivalent education and typically 12 years of experience, MS or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience
• Must have experience in CMC purification process development
• Must have experience in designing and executing virus clearance studies to enable IND or BLA regulatory filing
• Must have proven expertise in developing standard bioprocess unit operations such as chromatography separations (resin/membrane: affinity, CEX, AEX, HIC, MM) and filtration operations (depth filtration, virus filtration, sterile filtration, TFF)
• Proficient in writing methods and operating AKTA chromatographic instruments (such as AKTA Avant, AKTA Purifier, AKTA Pure, AKTA Ready or similar)
• Able to independently design, execute, and interpret laboratory experiments to answer scientific questions
• Has a strong understanding of analytical techniques, such as HPLC and ELISA
• Must be forward-thinking and be able to lead and contribute to scientific/technical discussions
• Able to independently learn, understand and execute novel/advanced scientific techniques
• Must have excellent attention to detail and ability to keep detailed written records
• Proven record of authoring publications, technical reports, regulatory documents, and presentations
• Has strong communication skills including verbal, written, and scientific data presentation
• Has excellent understanding of biochemistry and bioprocess engineering concepts
• Able to work collaboratively within and outside of the group
• Has proficiency with Microsoft Office software, ability to learn new software applications

Preferred:

• Has hands on experience with monoclonal antibody or antibody-like molecule purification across multiple scales (GMP, pilot and/or laboratory scale)
• Proven experience in chromatography or membrane separation mechanistic modeling
• Has a strong understanding of statistical tools and analysis

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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https://www.abbvie.com/join-us/reasonable-accommodations.html