Bulk Drug Substance Process Hygiene Lead

Hispanic Alliance for Career Enhancement; Cataluña; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading global biopharmaceutical company is seeking a Global Bulk Drug Substance Process Hygiene Technical Lead to ensure hygiene excellence across its BDS manufacturing. This role focuses on improving process hygiene, leading a Center of Excellence, and collaborating on capital projects. Candidates should have a technical degree and at least 7 years in BDS manufacturing with strong GMP knowledge and problem-solving abilities. Competitive benefits and salary based on individual factors, including geographic location.

Servicios

Paid time off

Medical/dental/vision insurance

401(k)

Short-term and long-term incentive programs

Formación

• 7+ years experience in BDS manufacturing with upstream/downstream expertise.
• Strong knowledge of GMP requirements and technical operations.
• Experience in operational budgeting related to hygiene risk.

Responsabilidades

• Provide oversight of process hygiene performance across global sites.
• Lead a Center of Excellence for BDS process hygiene.
• Collaborate with Global and Site Engineering for capital improvement.

Conocimientos

Technical problem-solving

Risk assessment

Communication skills

Process improvement

Educación

Bachelor’s degree in Chemical Engineering, Microbiology, Bioengineering, or similar

Descripción del empleo

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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Global Bulk Drug Substance (BDS) Process Hygiene Technical Lead plays a critical role in ensuring process hygiene excellence across AbbVie's global BDS manufacturing network. This is a cross‑functional leadership role that requires a deep understanding of BDS manufacturing and the ability to influence global site stakeholders and leadership. The Global BDS lead role is to improve and maintain a best‑in‑class global Process Hygiene Index across AbbVie's BDS network and standardize long‑term procedural and technical solutions to mitigate hygiene risks across all global BDS sites.

Responsibilities

• Provide global oversight of process hygiene performance and manage hygiene‑related risks across multiple BDS manufacturing sites and regions, including but not limited to: cell culture inoculation, production bioreactors, chromatography, ultrafiltration, and bulk fill.
• Lead a global Center of Excellence (CoE) for BDS process hygiene, focusing on risk awareness, procedural excellence, and technical innovation.
• Assess shop floor operations and FUE (Facility, Utility, and Equipment) design to identify process hygiene risks.
• Recommend and drive procedural updates and documentation governance aligned with hygiene best practices.
• Identify and champion innovative technical solutions to mitigate hygiene risk and standardize successful approaches network‑wide.
• Collaborate with Global and Site Engineering to drive capital improvement initiatives.
• Influence annual Capital Planning and Long‑Range Capital Planning processes by integrating hygiene‑driven project needs.
• Lead or support investigation of hygiene‑related events; drive root cause analysis and implement corrective actions.
• Develop and maintain analytical tools to report and track global process hygiene metrics.

Qualifications

• Education: Bachelor’s degree in a technical discipline e.g., Chemical Engineering, Microbiology, Bioengineering, or similar discipline.
• Experience: Minimum of 7 years in BDS manufacturing, with demonstrated expertise in upstream and downstream operations.
• Strong knowledge of GMP requirements and cross‑functional roles in technical operations, documentation, and quality systems.
• Proven track record in technical problem‑solving, risk assessment, and hygiene‑related process improvements.
• Experience with capital and operational budgeting, particularly with respect to hygiene risk mitigation and single‑use systems.
• Exceptional communication skills, with the ability to influence and lead across multiple functions and global sites.
• Demonstrated ability to prioritize and elevate competing demands effectively to site and network leadership.
• Deep understanding of shop floor operations and technical systems within BDS manufacturing.

Additional Information

• 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.
• This job is eligible to participate in our long‑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 and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html