Technical Operations Associate Director

BACKGROUND

Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd. (Zydus), is a commercial stage biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases. With an emphasis on commercialization, Sentynl looks to acquire, develop and commercialize well-differentiated products across a broad spectrum of therapeutic areas to address a variety of genetic orphan and neurological disorders.  To support its latest acquisitions, Sentynl is searching for a Technical Operations Associate Director.

SUMMARY

The Technical Operations (Tech Ops) Associate Director is responsible for executing and managing global supply chain, logistics and manufacturing process activities and will oversee day-to-day, end-to-end manufacturing technical operations of Sentynl’s development and commercial products. The Tech Ops Associate Director will also manage serialization, maintain internal inventory systems and work with cross-functional teams and external parties to ensure uninterrupted product flow into the global distribution network.

The candidate must have a strong knowledge of process chemistry, applicable cGMP regulations/systems and have the ability to make independent decisions based on regulations and requirements. This individual must demonstrate excellent leadership, communication, critical thinking, and organizational skills.


ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Oversee and manage manufacturing activities performed at Sentynl’s contract manufacturing organizations (CMOs), including supply agreement negotiations and contractual commitments.
  • Oversee global expanded access program product supply chain.
  • Lead production planning, including material management, product inventory management, and tracking of product supply and distribution, including serialization.
  • Conduct risk-assessments on supply chain, develop redundancies, disaster preparedness, and other strategies to reduce/eliminate supply chain delays.
  • Conduct monthly global inventory reconciliations for commercial and early access inventory.
  • Lead and implement efforts to improve manufacturing efficiencies of commercial products and troubleshoot manufacturing issues.
  • Oversee tech transfer, process development, and process qualification/validation activities.
  • Logistics, including management of domestic and international product shipping requirements.
    • Support developing and updating policies and procedures to comply with good distribution practices (GDP) and import/export regulations.
    • Supporting transportation and logistics activities for domestic and international movements of Drug Product and Finished Goods between manufacturing sites and distribution centers.
  • Provide technical support and technical oversight of operations, including but not limited to process chemistry, sterile fill operations, lyophilization, analytical testing, packaging, and labeling activities.
  • Provide technical oversight for product recall activities as required.

KNOWLEDGE/SKILLS/ABILITIES

  • Expert knowledge of supply chain (commercial and clinical), vendor management, raw materials, process chemistry, analytical testing, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
  • Strong working knowledge of cGMP FDA regulations (21 CFR Parts 210, 211).
  • Excellent communication (verbal and written), organizational, interpersonal, and computer skills.
  • Pervasive focus on helping patients.
  • Excellent interpersonal skills with a demonstrated track record of achieving results and optimizing team performance while adhering to the highest medical and ethical standards.
  • Ability to work independently and as part of a team with a strong sense of urgency and initiative.
  • Advanced Microsoft Excel Skills.
  • Adeptness at building collaborative relationships with internal and external stakeholders.
  • Demonstrated problem solving and conflict resolution skills.
  • Strong understanding of industry, compliance, and regulatory frameworks and trends.
  • Ability to manage consultants and vendors.

EDUCATION/EXPERIENCE

  • Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science field.
  • Minimum of 10 years of relevant experience in tech ops in the pharmaceutical industry.
  • Experience taking lead on complex projects and processes within the pharmaceutical industry.
  • Previous experience with tech ops and managing CMOs.
  • Willing to travel both domestically and international (minimum 20%).

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job.

  • Normal office conditions.
  • Routine travel will be required between various locations in US and occasional international travels. Up to 20% travel.

CORE VALUES & COMPETENCIES

Growth

  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation

Accountability

  • Results Oriented
  • Ensures Accountability
  • Decision Quality

Transparency

  • Courage
  • Collaboration
  • Instills Trust

Ethics

  • Compliant
  • Unwavering commitment to doing what is right
  • Seeks guidance when unsure

Sentynl Therapeutics, Inc. offers a competitive salary program and an attractive benefits package that includes:

  • Medical/Dental/Vision Insurance
  • Company paid Life Insurance, Short-term Disability and Long-term Disability
  • 401(k) plan with a generous employer match
  • Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager.
  • Paid Holidays
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