Associate Director mRNA Vaccine Manufacturing & Tech Transfer

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jan 15, 2022
Ref
R-158241
Required Education
Bachelors Degree
Position Type
Full time
Job Description

Job Summary:

The individual provides leadership for a team of technical staff and serves as a subject matter expert responsible for oversight of development, scale-up, tech transfer and manufacture of mRNA vaccines for pre-clinical and clinical studies. Supports projects that will drive future growth through process improvements.  Uses scientific and GLP/GMP knowledge to ensure compliance with company and regulatory agency guidelines as it relates to equipment, materials, facilities, and process development, scale-up and manufacture.

Major Responsibilities:

Process and Product Development:

  • Represents Technical Development and interfaces with MS&T and Operations to scale-up and tech transfer processes for the manufacture of seasonal and pandemic mRNA vaccines.

  • Leads development and scale-up of complex processes and communicates risk-based assessments and recommendations to key stake holders.

  • Leads TD mRNA vaccine technical team responsible for scale-up, tech transfer, and manufacture of pre-clinical and clinical material.

  • Represent TD on cross-functional teams related to mRNA-based vaccine program.

  • Proactively identifies development and improvement opportunities, generates a supportive business case, and supports cross-functional teams to deliver those opportunities.

  • Uses a data driven approach to progress development deliverables.

  • Responsible for using scientific and GLP/GMP knowledge to support site and global mRNA vaccine projects.

People Management:

  • Direct supervisor for GMP manufacturing team responsible for production of clinical trial material.

  • Direct supervisor for SME technical team responsible for CMC development, scale-up, and tech transfer mRNA vaccine products/processes.

  • Provides ongoing performance feedback to direct reports.

  • Provides scientific/technical guidance and mentorship to TD mRNA Process team.

  • Models a culture of safety, ensures team adheres to requirements, and identifies and implements improvements.

  • Maintains a state of compliance for team through regular review of training and implementing training curricula improvements.

  • Serves as subject matter expert and general scientific resource for colleagues with less experience.

Operations/Quality Support:

  • Serves as interface between TD and MS&T/Operations by representing TD department in cross-functional forums and informing stakeholder of key information to support the scale-up, tech transfer, and manufacture of pre-clinical and clinical material.

  • Utilizes knowledge and experience of GLP/GMP as well as mRNA vaccines to provide technical support for development and manufacture of drug substance and drug product.

  • Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations.

Other:

  • Generates data summaries and presents project progress for internal audiences and key stakeholders in other groups (Operations, MS&T, QA, QC). 

  • Completes all individual training and maintains a state of compliance.

  • Adheres to all safety requirements.


Minimum Qualifications:

  • Bachelor’s Degree, Master's Degree or PhD in related scientific field

  • 10+ years relevant industry experience

  • Requires in-depth conceptual and practical expertise in own technical or scientific discipline (focus on mRNA vaccines).

  • Technical expertise in mRNA synthesis, lipid nanoparticle (LNP) formulation required.

  • Experience with GLP and GMP compliance and manufacturing required.

  • Experience writing content for technical documentation including SOPs, work instructions, technical protocols and reports, and technical presentations.

  • Experience presenting complex technical concepts to a wide range of audiences of varying technical depth.

  • Experience with direct reports; managing teams of individual scientific/technical contributors (i.e. scientists, engineers) required.

  • Ability to lead, drive and motivate people to achieve goals.

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

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