External Large Molecule Analytical Sciences Group - West Point, United States - MSD

MSD
MSD
Verified Company
West Point, United States

2 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
The Global Quality

  • Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of latestage pipeline programs through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics), and Cross-Modality Compounds (e.g., Antibody-Drug Conjugates).


This is an opportunity to build and oversee a high performing team focused external analytical sciences that enables our company's strategic priorities to deliver life-changing products through robust launch of pipeline products and uninterrupted supply of commercial product.

This role involves not only direct people management but also developing external network partnerships and implementing proactive and standardized analytical engagement with external focus factories and external providers.

Additionally, this position will involve strong collaboration across multiple internal functions including but not limited to analytical program leaders and analytical method experts, AR&D, procurement, process and external manufacturing leads, quality and regulatory.


Responsibilities include but are not limited to:

  • People management for the External Large Molecule Analytical Sciences Group
  • Build and sustain high performing team focused on external analytical technical activities.
  • Core membership in joint steering teams with external providers
  • Engage with external providers and AR&D to build strong relationships that identify, manage, and as needed escalate risks and challenges in a proactive and collaborative manner.
  • Participate in analytical testing lab siting efforts (e.g., due diligence) with a strategic analytical siting mindset.
  • Review and approve technical documentation including support of complex deviations and laboratory investigations as needed.
  • Drive continuous improvement initiatives to enhance the analytical capability and robustness of external testing through implementation of strategic analytical efforts, best practices and assay monitoring.
  • Build and manage project plans, timelines, and schedules to effectively meet project timelines and deliverables.
  • Collaborate with departmental and crossfunctional commercial manufacturing teams to support analytical technical components of facility sustainability activities.
  • Support technical readiness to ensure our manufacturing sites are prepared for inspections from multiple agencies (i.e., FDA, EMA, PMDA)

Minimum Education Required and Experience:


  • Bachelor's Degree (BA/BS) with a concentration in biology, chemistry, biochemistry, or related science with ten (10) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation;
    OR:
  • Master's Degree (MA/MS) with a concentration in biology, chemistry, biochemistry, or related science with eight (8) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation;
    OR:
  • PhD with a concentration in biology, chemistry, biochemistry, or related science with five (5) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation.

Required Skills and Experience:


  • Direct People management experience
  • At least 8 years working experience in a GXP laboratory environment in the area of large molecules (vaccines, biologics) analytics or Cross-Modality Compounds
  • Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, and/or Quality control.
  • Experience with regulatory requirements and guidelines according to ICH, USP, Ph. Eur., and JP.
  • Strong organizational and project management skills to handle multiple project associated tasks simultaneously.
  • Strong oral and written communication skills to effectively communicate and collaborate with many functional areas.
  • QC Laboratory Due Diligence Experience

Preferred Skills and Experience:


  • Knowledge of deviation management and change control processes
  • Ability to analyze, interpret, and troubleshoot analytical data.
  • Selfmotivated with a positive, proactive, and serviceoriented mindset.
  • Capability to adapt and be flexible in a fast paced crossfunctional team working environment.
  • Experience with laboratory data management systems (i.e., LIMS)
  • Experience with software automation/digital systems (e.g., Veeva Vault, MEDs, IPI, Spotfire)

NOTICE
FOR
INTERNAL
APPLICANTS


If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.

To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles tha
More jobs from MSD
See all jobs of MSD