Senior Scientist, I- Analytical Development ( On-site-Worcester, MA)

Allergan; Lincoln (NE); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading company in the biopharmaceutical industry is seeking a highly motivated Senior Scientist I to join their Analytical Development team. The role involves developing and qualifying analytical methods for biological entities, ensuring compliance, and collaborating with various teams to meet business objectives. Candidates should have a strong background in method development and experience with techniques such as ELISA and qPCR.

Benefits

Paid time off

Medical, dental, vision insurance

401(k) plan

Short-term incentive programs

Long-term incentive programs

Qualifications

• Typically 10 years experience with Bachelor's, 8 years with Master's, or PhD with no experience.
• Experience in method development, qualification, validation, and transfer for biological products.

Responsibilities

• Partner with Analytical Development groups for commercial method readiness.
• Author regulatory submissions and support inspections.
• Conduct periodic reviews of methods and implement necessary changes.

Skills

Leadership

Problem Solving

Education

Bachelor’s Degree

Master’s Degree

PhD

Tools

ELISA

qPCR

SPR

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

We are seeking a highly motivated Senior Scientist I to join our Analytical Development team in the Product Development Science and Technology, Biologics Development Launch division. Our team is responsible for the development, qualification, and execution of analytical methods to provide product and process understanding for biological entities from discovery through commercial stages.

The successful candidate will be a part of the Biomolecular Interaction Group which is mainly focused on method development and implementation of various immunoassays to monitor process impurities and to assess potency of AbbVie’s Biologics to support product and process development for early-phase, late-phase, and commercial programs. Some of the techniques/methods utilized in the group include 1) ELISAs to monitor and detect process related impurities; 2) surface plasmon resonance using Biacore for assessment of antigen binding and binding of antibody Fc receptors; and 3) qPCR to measure levels of residual DNA and mycoplasma. The role will involves managing all analytical aspects of biologics products on the market, overseeing commercial methods throughout their lifecycle - from method transfer, performance monitoring, troubleshooting, to method enhancement. The individual will also play a key role in establishing commercial product specifications, stability programs, and regulatory filings. Collaboration with other analytical teams, process development, global QC, and manufacturing science and technology groups is a crucial part of this role to meet business objectives and program milestones.

Responsibilities:

• Partner with Analytical Development groups to achieve commercial method readiness using traditional and advanced analytical techniques, including but not limited to ELISA, bioassays, spectrophotometric and compendial methods.
• Participate in cross-functional, multi-site, global meetings / projects and oversee commercial analytical method transfer between sites, product/process investigations, method performance monitoring and troubleshooting.
• Establish scientifically sound, analytical lifecycle strategies, including methods, stability, specification and change management that meet Health Authority best practices and expectations.
• Participate in the preparation and review of technical documents to ensure global compliance - including validation protocols and reports, reference standard qualification reports and analytical test procedures.
• Author regulatory submissions, support regulatory inspections and provide scientifically sound responses to agency deficiency letters.
• Conduct periodic review of methods and work with program leads to design, execute remediation experiments, and implement changes to new or existing commercial methods when necessary.

Qualifications

• Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.
• Industry experience in method development, qualification, validation, and method transfer in support of development and/or commercialization of biological products.
• Methods including but not limited to ELISA, western blot, qPCR, ddPCR, SPR and automation
• Ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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