Sr Engineer, Process And Packaging Development

TITLE:

Sr Engineer, Process and Packaging Development

Title: Sr Engineer, Process and Packaging Development

Reports To: Director, CMC

Location: Ft. Collins

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:

Indivior is seeking an experienced technical leader to manage and support at the interface between R&D CMC (Chemistry, Manufacturing and Controls) and our chosen manufacturing partners. This individual will work to develop exciting new manufacturing processes and packaging systems and also to support improvements to existing drug products in the field of addiction therapy and associated co-morbidities, from early phase clinical trials through tech transfer to commercial manufacturing and support of post-approval improvements.

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

• Assist in the evaluation and management of CMOs, contract research organizations and suppliers as needed

• Lead the interface between R&D and commercial supply for projects within the new and existing product pipeline. Experience with aseptic fill/finish is preferred.

• Collaborate closely within Process Development R&D and with the commercial manufacturing team to design commercially viable manufacturing processes and packaging solutions

• Lead in the development of engineering protocols for both in-house or 3rd party manufacturing

• Manage the technology transfer of drug product manufacture from R&D to commercial CMOs for Phase 2/3 clinical trials and commercialization, ensuring all aspects of the development, including process scale-up and packaging, controls, and process validation are effectively managed with any issues highlighted to stakeholders in a timely manner

• Contribute to the post-approval change management of existing products, ensuring that Indivior or Contractor led change has appropriate technical oversight and sanction from CMC technical SME(s)

• Create/edit SOPs, protocols, and reports in support of technology transfer and late-stage process development and clinical manufacturing activities

• Ensure that Tech Transfer files accurately capture the detailed know-how associated with products manufactured by or for Indivior ensuring on-going quality and technical ownership of manufacturing processes

• Collaborate on the qualifications for new or modified processes or equipment/systems

• Collaborate with Quality and Supply teams to ensure that the clinical, technology transfer, and validation supplies are delivered reliably and safely, manufactured by cGMP principles

• Manage assigned projects, ensuring the project milestones are delivered on time and to plan

• Lead Drug Product manufacturing strategy and planning meetings, risk assessments and stakeholder interactions to leverage Indivior's technical expertise and insight to drive the right decisions at the right time and mitigate risk

• Apply the principles of Quality by Design

• Draft manufacturing and packaging sections for Regulatory Filings

• Assess the availability and appropriateness of raw materials and components, and develop specifications for these items that ensure drug product quality

• Up to 20% travel - Domestically and Internationally.

Key Challenges:

• Management of 3rd party vendors to deliver against Indivior timelines and Quality expectations

• Working in a challenging, fast paced environment, on varied projects

• Produce work of the highest quality in accordance with the relevant regulatory guidelines to challenging time scales

• Technical problem solving and troubleshooting when required, ensuring issues are addressed without delay to projects

• The ability to think laterally in order to apply novel solutions and supporting justifications to challenging problems or situations.

• Managing manufacturing development aspects of new drug development from early phase through to registration and beyond

MINIMUM QUALIFICATIONS:

• A degree in chemical engineering, chemistry or similar

• 5+ years experience in pharmaceutical product development and manufacturing

• Experience in GMP manufacturing of pharmaceutical drug products, parenteral forms an advantage

• Experience in process development, scale-up, validation and continuous improvement

• A high level of technical agility

• Excellent written and verbal communication skills to join the R&D team in the field of drug product manufacturing process development.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

• A 'See it Own it Make it Happen', attitude and proven ability to evaluate and communicate risks.

• Experience working with 3rd party partners to deliver project goals

• Experience in manufacture and packing of parenteral dosage forms; experience with other dosage forms is advantageous

• Proven experience and practical knowledge in scale-up and process validation

• Experience within a GMP pharmaceutical environment with a proven track record of delivering high quality work to tight deadlines

• Ability to solve complex technical problems using experience, knowledge, research and advice

• Demonstrates scientific excellence in technical field in all activities, deliverables and interactions

• Demonstrates team collaboration and professional behaviors to align with Indivior guiding principles and core values

• Excellent communication skills and a proven ability to negotiate

• Proven ability to work under pressure, as a part of a team, without compromising quality and delivery

BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 3 weeks' vacation plus floating holidays and sick leave

• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay

• U.S. Employee Stock Purchase Plan- 15% Discount

• Comprehensive Medical, Dental, Vision, Life and Disability coverage

• Health and Dependent Care Flex Spending options

• Adoption assistance

• Tuition reimbursement

• Leverage Concierge/personal assistance services

• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage

• Gym, fitness facility and cell phone discounts

• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

GUIDING PRINCIPLES:

Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled