Pharmaceutical Manufacturing Operations Specialist
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. AbbVie is always striving to find top scientists/associates to work at our Campbell site. Be Bold and grow your manufacturing biopharmaceutical career with the pharmaceutical and medical device industry leader!
Pharmaceutical Manufacturing Operations Specialist- Biopharmaceutical/GMP
An “ideal” candidate for this role is someone with sound knowledge of the biopharmaceutical manufacturing environment and leadership in project management, and compliance.
Successful candidates will have the following types of experience:
Primary responsibility is to manufacture marketed drug substance, and implementing improvements to the equipment, procedures and systems used in Manufacturing department at Bioscience Laboratories Campbell.
Additional responsibilities include support of ongoing clinical products and projects related to new product introduction and technical transfer
Be a trusted and expert partner in Manufacturing in a GMP environment. Technical expertise should include thorough knowledge of biopharmaceutical manufacturing technology and regulatory requirements, normally acquired through a progressive operation experience in a GMP environment. Especially critical is high level knowledge and hands experience in the areas of microbiology, fermentation, aseptic processing, and protein purification techniques.
Be a compliance expert. You will lead the completion and review of Manufacturing documentation. This includes forms, batch production records and any other quality system documentations. In addition, you will demonstrate the following skills:
Innovate as a project management leader. The position will need to be experienced in project management oversight and leading project teams and coordination of team activities. This position will also oversee capital expenditure projects and function as a project manager. In addition, you will demonstrate the following skills:
Position requires individual to work with Select Agents. Access to, and use of, select agents is covered by Federal policies. Violation of, or failing to support the intent of, Select Agent policies, regulations, or laws can result in substantial fines and/or imprisonment, as well as civil monetary penalties and are considered grounds for dismissal.
Ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
BA / BS in a science or engineering related discipline (Microbiology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering) with a minimum 7 years of experience in a GMP manufacturing environment. OR MA / MS in a science or engineering related discipline (Microbiology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering) with a minimum 3 years of experience in a GMP manufacturing environment.
Minimum 2 years of hands on experience of fermentation, purification or pharmaceutical manufacturing process.
3 years of supervisor or project management experience.
Strong technical writing skills.
Extensive experience in resolving complex production non-conformances, implementing CAPA, leading improvement projects, commissioning and validating systems / processes are a must.
Previous experience in facility or systems modification / design, as well as specifying equipment, creating systems and Standard Operating Procedures (SOPs) is also required.
Familiar with other enterprise systems, for example, SAP, RAM, and SCADA system.
Must be able to acquire security background clearance from US Department of Commerce, FBI and CDC.
Representative of the Manufacturing department in External audit (for example, FDA, HPRA, CDC) as well as internal audit.
Previous experience with LEAN or Six Sigma is desirable, but not required.
Occasional support and domestic travel as needed (up to 5%).
ABBVIE LEADERSHIP SKILLS:
Open and Authentic
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
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.