AbbVie

Sr Scientist, Sterile Liquids Product Development

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Feb 20, 2021
Ref
205432
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

You will plan, direct, and execute drug product formulation & manufacturing process development activities in support of development of new products intended for clinical trials and commercialization with focus on sterile liquid dosage forms including emulsions, solutions, gels and suspensions. You will conduct research in the area of formulation and process sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.

• The essential components of this position are in-depth understanding of pharmaceutical formulation principles, manufacturing process unit operations, global CMC regulatory requirements as well as strong organizational skills to develop formulations intended for clinical trials and commercialization. Specifically,
• Provide scientific and technical leadership for product formulation development projects and in general, Pharmaceutical Development function. Applies the principles of quality by design (QbD) and statistical process design/analysis to formulation and process development.
• Demonstrate scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
• Represent department at CMC/Project Team meetings and work closely with other Pharmaceutical Sciences departments, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
• Apply current CMC regulatory requirements and guidance's to support global registration of new products.
• Exhibit leadership skills that result in good performance and career development of junior staff.
• Keeps abreast of current developments in pharmaceutical technology, leading edge technologies and regulatory affairs to contribute to the technical base at AbbVie

Key Responsibilities:
• Plan, direct, and execute drug product formulation & manufacturing process development activities in support of development of new products intended for clinical trials and commercialization with focus on sterile liquid dosage forms. Apply the principles of Quality by Design and statistical process design/analysis to formulation and process development. Conduct research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.
• Provide scientific and technical leadership on one or more areas of formulation development and dosage form design. Develops and maintains a current in-depth knowledge of global CMC regulatory submission requirements and GLP/GMP requirements. Review internal and external technical documents, writes technical memos/reports, patents, scientific articles. Presents scientific/technical seminar annually at Pharmaceutical Development Seminar series.
• Plan, direct, and execute drug product formulation & manufacturing process development activities in support of development of new products intended for clinical trials and commercialization with focus on sterile liquid dosage forms. Applies the principles of Quality by Design and statistical process design/analysis to formulation and process development. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products. Represent department at CMC/project team meetings and work closely with other Pharmaceutical Sciences departments, Process Chemistry, Toxicology, Regulatory Affairs, Quality,
• Perform supervisory duties including reviewing progress of assignments against established project timelines, assistance on daily work direction, problem solving and advice to junior staff to enhance their work effectiveness in generating data, ensuring good record keeping of all laboratory data, adherence to lab safety and general staff development. Clinical Development and Marketing to meet project timelines and objectives.

Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Allergan internal and applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Qualifications

• Required: Ph.D.-level or MS - level education in pharmaceutical sciences or chemical engineering with 2-3 years and 5+ years of relevant industrial experience.
• Must be able to operate independently and utilize knowledge of pharmaceutical science, chemical engineering, literature and experience to guide decisions in complex situations.
• Knowledge of fundamental applications of statistics is preferred. In-depth understanding of pharmaceutical formulation and process development principles, manufacturing equipment design and technologies, as well as strong organizational skills to develop formulations and manufacturing processes intended for clinical trials and commercialization.
• Demonstrated scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
• Excellent scientific approach and organization skills. Proven problem solving skills must be demonstrated.
• Possesses excellent communication (oral and written) and interpersonal skills.
• Ability to establish and maintain effective relationships with management, co-workers and customers and work well in a team environment.
• Self-motivated and demonstrated willingness to take on new approaches/technologies and additional responsibilities.
• Articulates ideas in a clear, concise manner. Actively listens to and encourages input before taking action.
• Consistently delivers on commitments and responds to customers' needs in a timely and courteous manner.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.