The primary scope of the role is to manufacture marketed drug substance, and implementing improvements to the equipment, procedures and systems used in the Manufacturing department at Bioscience Laboratories Irvine. Additional responsibilities of the Specialist include support of ongoing clinical products and projects related to new product introduction and technical transfer.
- Utilize technical expertise and thorough knowledge of biopharmaceutical manufacturing technology and regulatory requirements, normally acquired through a progressive operation experience in a GMP environment.
- Demonstrate high-level knowledge and hands on experience in the areas of microbiology, fermentation, aseptic processing, and protein purification techniques.
- Project Management: The position will include 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.
- Manufacturing Compliance: Completion and review of Manufacturing documentation. This includes forms, batch production records and any other quality system documentation.
- 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.
- Provide training and guidance on the staff to meet the goals of the department. When appropriate, assist in providing leadership on project teams.
- 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.
- 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.
- 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 in fermentation, purification or pharmaceutical manufacturing process.
- 3 years of supervisor or project management experience.
- 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.
- Strong technical writing skills.
- Strong proficiency in Microsoft Word, Excel, PowerPoint.
- Familiar with other enterprise systems such as SAP, RAM, and SCADA.
Essential Knowledge, Skills & Abilities:
- Strong leadership, organizational, communication, technical and writing skills.
- Project management experience and the ability to lead cross-functional teams.
- Previous experience with LEAN or Six Sigma is desirable, but not required.
- Occasional support and domestic travel as needed (up to 5%).
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 in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less 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/vision insurance and 401(k) to eligible employees
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.