Director, Manufacturing Sciences and Technology (MSAT)
Company: Maravai LifeSciences
Location: San Diego
Posted on: January 27, 2023
TriLink Biotechnologies, a Maravai LifeSciences company is
seeking a Director, Manufacturing Sciences and Technology (MSAT) to
join our growing team.The Director of Manufacturing Science and
Technology (MSAT) is a leadership role and will be responsible for
technical leadership and support of Contract Development and
Manufacturing Organization (CDMO) manufacturing operations for
Nucleic Acid Products (NAP) and Nucleic Acid Services (NAS). The
candidate will be responsible to lead, manage and develop a
department of employees responsible for MSAT activities in
alignment with NAP and NAS.
The role will report into the Engineering organization and focus on
liaising with internal and external clients to transfer and support
their respective manufacturing processes.
Description of Duties:
- Act as a subject matter expert in plasmid, mRNA production, and
small molecule manufacturing operations and sciences
- Manage a team; lead, develop and implement scientifically sound
and phase appropriate process validation policies and procedures
based on current regulations, industry standards and industry
- Hands-On leader with high level of engagement within MSAT
function and cross-functionally.
- Provide mentorship and developmental feedback to create and
foster a collaborative work environment. Responsible to coach,
mentor, collaborate, partner, at all levels with high visibility
- Partners in the development and execution of long-term MSAT
strategy in line with NAP and NAS initiatives to include new
technology and process introduction into manufacturing.
- Active management of employees, reflecting on problems,
solutions, and challenges.
- Accountable for creating a culture of continuous improvement,
that contributes towards becoming a learning organization.
- Continuously seek to optimize the manufacturing processes to
ensure effective use of capacity and minimize costs.
- Provide leadership and direction for Site MSAT and
manufacturing Technical SMEs to define the process validation
- Interface cross-functionally with Process Development, Quality,
Manufacturing, and Process Engineering to implement new processes
- Explore, assess and recommend new manufacturing unit operations
which improves manufacturing processes from a cost, efficiency,
quality, and compliance.
- Prepare and present regular updates indicating progress, risks,
and future plans for NAP and NAS projects.
- Accountable for technical review of manufacturing batch
records, SOPs, deviations, and investigations.
- Accountable for design and oversee experiments in collaboration
with Process Development/Process Engineering to support
investigations and process improvements.
- Collaborate cross-functionally to execute risk mitigations and
initiatives to improve the quality and robustness for NAP and
- Accountable of robustness and capability of product's
monitoring while using statistical analysis to monitor Critical
Process Parameters (CPP) and Critical Quality Attributes
- Identify and implement process improvements to support NAP and
- Support change controls, audits, deviations, and Quality Risk
- Own Quality by design program for NAP and NAS.
- Support production related investigations, ensuring compliance
with internal standards and regulatory requirements.
- BS./M.S./Ph.D. in Biochemistry, Chemical/Biomedical Engineering
or Biology or equivalent with 15+ years process validation,
technology transfer or biotech/pharmaceutical manufacturing
- 6+ years of directly related industry experience in GMP
manufacturing with direct/indirect experience managing a team as
well as leadership experience leading teams, projects and
- Cell culture, cell therapy, or aseptic and final fill
processing experience (preferred)
- Solid understanding of principles and concepts of Lean Six
Sigma to improve process capability (preferred)
- Thorough understanding of cGMP manufacturing (must).
- Excellent communication and written skills with direct
experience supporting significant strategy development &
- Thorough understanding of regulatory/compendial requirements
used in biotech/pharmaceutical manufacturing.
- Experience leading technical transfers, qualification,
validation, and implementing multivariant process monitoring
- Strong interpersonal and leadership skills to work with teams
in different functions and organizations.
- Ability to effectively work in cross functional teams, meet
deadlines, and prioritize responsibilities.
- Lean Manufacturing experience is desired.
- Experience with manufacturing automation and Manufacturing
Execution Systems (MES)
- Knowledge of data management tools and statistical
- Willingness to think outside of the box and adapt best
practices in a novel technology environment.
- Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485
requirements a plus
The anticipated salary range for this position is 195,000 -
220,000. In addition, highly competitive long-term incentives in
the form of company equity, bonus participation and company
sponsored benefits are provided as part of the total compensation
package. The salary offer will depend on multiple factors which may
include the successful candidate's skills, experience and other
qualifications, as well as the location of the role.
Keywords: Maravai LifeSciences, San Diego , Director, Manufacturing Sciences and Technology (MSAT), Executive , San Diego, California
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