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Senior Scientist I, Biologics Drug Product Development
3 months ago
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The incumbent in this role will lead the formulation development of protein biologics from early development through commercialization, with a specific focus on neurotoxins for therapeutics and aesthetic use. The incumbent must be familiar with the activities associated with late-stage biologics development. This position requires laboratory work in areas requiring select agents and Toxins access (i.e. Biosafety level 2 laboratories). The incumbent will also take on some lab management responsibilities so familiarity with equipment and processes used in drug product formulation and product development is required. Access and use of select agents is highly regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. Experience in the SAT environment is required to lead the activities expected of the position. Experience in SAIS is required.
Responsibilities
Develop preclinical and clinical formulations, including liquid and lyophilized dosage forms, and related drug product manufacturing processes.Transfer drug product manufacturing process to internal and external fill-finish facilities and provide on-site support as needed.Support development stability and clinical in-use studies to guide dose solution administration.Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.Lead drug product development teams in the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines.Actively interact with CMC members and other AbbVie stakeholders to enable the successful development of AbbVie drug products.Lead some lab management activities and supervise staff in lab operations.Qualifications
Masters or Doctorate degree in biochemistry, biophysics, molecular biology, or related field with 10+ years of industry experience (Masters) or 4+ years of industry experience (Ph.D.). A strong technical background encompassing process development and formulation development is required.Prior experience in protein and lipid nanoparticle formulations, process development, vacuum drying and lyophilization are preferred.Prior experience in scale up and technical transfer of aseptic manufacturing processes are desirable.Demonstrated experience in driving drug product development programs is a strong plus.Excellent communication and written skills are required.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this postingbased on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more orless than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of payis a considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidandmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
