AbbVie

Pharmaceutical Manufacturing Operations Specialist

Employer
AbbVie
Location
Campbell, CA, United States
Posted
Oct 06, 2020
Ref
203593
Required Education
Bachelors Degree
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 .

Job Description

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

YOU WILL:

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:
  • Improve the technical capabilities and quality practices within the department. Coordinate activities and resolve issues across the department, other groups, and/or projects.
  • Respond to and/or resolve recurring technical or processing issues. Develop and implement novel approaches to solving non-routine technical problems. Communicate information effectively through updates, reports, and summaries. Lead improvements in processes and methods that reinforce cGMP within the department and/or across the site.
  • Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems. Conduct investigations demonstrate strong technical and problem-solving skills, and excellent technical writing 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:

  • The Specialist will also represent the department as the SME and lead multi-disciplinary teams or committees.
  • Provide routine updates on progress, status, and issues associated with campaigns/projects.
  • Provide support and/or direction to junior staff when necessary.
  • Exercise sound judgment when making decisions. Make critical decisions in collaboration with key stakeholders.
  • Demonstrate accountability for personal, departmental, and organizational initiatives.
  • 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.


Qualifications

YOU BRING:
  • 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:
  • Excellence Focused
  • Boundaryless Mindset
  • Open and Authentic
  • Strategic Foresight


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.