Regulatory & Compliance Knowledge

• Strong understanding of regulatory and compliance requirements applicable to single-use technologies used in biopharmaceutical and pharmaceutical manufacturing.

• Working knowledge of Extractables & Leachables (E&L), supplier qualification programs, GMP/cGMP expectations, change control, quality risk management, sterility assurance, contamination control, validation requirements, and regulatory expectations from US FDA, EMA, MHRA, PMDA, and other global agencies.

• Awareness of BPOG Single-Use guidance and USP / ISO standards relevant to single-use systems, fluid contact materials, sterilization, biocompatibility, and particulate control.

Personal Attributes

• Purpose-driven, with passion for discovery and determination to overcome challenges that advance life-changing science.

• Customer-focused, solution-oriented, and able to convert technical insight into meaningful business impact.

• Strong leadership, communication, influencing, and cross-functional collaboration skills.

Who You Are

• A Subject Matter Expert (SME) who partners closely with commercial teams, product managers, quality teams, and R&D scientists to achieve business objectives.

• Possess deep understanding of bioprocessing workflows and/or sterile pharmaceutical manufacturing operations.

• Strong understanding of customer technical challenges, process requirements, material requirements, and regulatory expectations.

• Capable of engaging effectively with stakeholders across Process Development, Manufacturing, Engineering, Validation, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and Procurement.

• Demonstrated project management and execution skills, with the ability to manage and prioritize multiple technical engagements and strategic opportunities.

• Able to develop and maintain strong technical relationships with targeted key accounts.

• Passionate about driving innovation and continuously improving AFH products, solutions, and service offerings.

• Possess strong knowledge of regulatory expectations associated with single-use assemblies, fluid handling systems, and critical process components used in regulated manufacturing environments.

How You Will Thrive and Create an Impact

• Play a key role in identifying, qualifying, and prioritizing project opportunities, ensuring effective support for both internal and external customers.

• Contribute to the technical positioning of AFH products within customer manufacturing processes and influence strategic decision-making.

• Improve the quality, competitiveness, and value proposition of AFH products and service offerings.

• Gather, compile, and analyze Voice of Customer (VOC) insights to identify unmet needs and create differentiated solutions.

• Develop a deep understanding of the competitive landscape and emerging market trends to guide future product and service development.

• Stay current with industry, technology, and regulatory developments and communicate insights across the organization.

• Support local and global sales processes, strategic account management initiatives, and business growth objectives.

• Build and maintain strong technical relationships with key stakeholders and decision-makers within strategic customer accounts.

• Provide technical and regulatory guidance regarding implementation, qualification, validation, and lifecycle management of single-use systems.

• Support customer discussions related to supplier qualification, extractables and leachables assessments, contamination control strategies, particulate risk management, sterilization validation, and change management processes.

• Collaborate with Quality, Regulatory Affairs, Product Management, Operations, and R&D teams to ensure AFH solutions align with current and evolving regulations and standards.

• Participate in customer audits, technical reviews, product evaluations, and qualification activities as required.

• Support both biopharmaceutical and sterile pharmaceutical manufacturing customers in achieving compliance, operational excellence, and process optimization.

Preferred Industry Experience

Candidates with experience supporting leading biopharmaceutical, vaccine, CDMO, biologics, and sterile injectable pharmaceutical manufacturers supplying regulated markets such as US FDA, EMA, MHRA, PMDA, and other ICH-regulated regions will be highly preferred.

Biopharma / Biotech Applications

Sterile Injectable / Regulated Pharma Applications

Monoclonal antibodies (mAbs)

VaccinesRecombinant proteins

Cell & gene therapies

Plasma products

CDMO biologics manufacturing

Aseptic / fill-finish operations

Sterile injectables

Small Volume Parenterals (SVPs)

Large Volume Parenterals (LVPs)

Complex generic injectables

US & EU regulated-market supply

Success Profile

Ideal Candidate Profile
The ideal candidate combines deep bioprocessing and pharmaceutical manufacturing expertise, strong understanding of single-use technologies, knowledge of regulatory and quality requirements for regulated markets, proven technical sales and key account management experience, leadership capability to build high-performing technical teams, and the ability to translate customer needs into commercially successful solutions.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by

employees assigned to this classification. They are not intended to be construed as an exhaustive list of

all responsibilities, duties, and skills required of employees assigned to this position.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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3rd party non-solicitation policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation

Originally posted on Himalayas