Lead Scientist, Analytical Development

TITLE:

Lead Scientist, Analytical Development

Title: Lead Scientist – Analytical Development

Reports To: Manager or Director Drug Substance Development

Location: Hull, UK

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). 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. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time.  Our purpose is to bring science-based, life-transforming treatments to patients.  We strive to help eliminate the stigma of addiction.  We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation.  We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

Indivior is seeking a highly experienced laboratory facing analytical development scientist to join the Drug Substance Development function of the Indivior R&D team to support the development of new small molecule compounds in the field of addiction treatment.  The overarching goal of our work is to establish the fundamental knowledge needed to supply drug substance throughout pre-clinical and clinical development and the transition of programmes to key regulatory filings and commercial manufacture. The drug substance development team collaborates with our own drug substance manufacturing facility and a network of 3rd party partners. Our state of the art, purpose-built R&D facility offers both non-GMP and GMP analytical capabilities. Our goal is to create an environment where everyone can contribute their best work, do their best science and to develop their skills and knowledge.

ESSENTIAL FUNCTIONS:

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

• Lead Analytical Development support to all aspects of drug substance development.
• Carry out or coordinate analysis including sample analysis, method development, method transfer, method validation, stability studies in an effective and timely manner.
• Demonstrate scientific excellence and solve complex technical problems using experience, knowledge, research and advice.
• Maintain the analytical laboratory and stability cabinets to cGMP standards.
• Review and Approve GMP data.
• Author and review analytical development reports.
• Actively participate in project update and planning meetings, risk assessments and stakeholder interactions to leverage your analytical science expertise to drive the right decisions at the right time.
• Maintain a strong working knowledge of ICH guidelines, EMA and FDA Guidance for Industry and apply the principles of Quality by Design.
• Lead the continuous improvement of the analytical development function with respect to new techniques, technologies or processes.
• Manage, supervise and coach junior members of the team as required.

MINIMUM QUALIFICATIONS:

• A degree in chemistry or related discipline (2.1 or 1st preferred)
• >5 years analytical development experience in a pharmaceutical environment including experience of drug substance analytical development.

Travel: Limited UK and European.

COMPETENCIES/CONDUCT:  

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

Personal Attributes

• A nimble learner with a growth and self-development mindset.
• Proven technical problem-solving skills over a wide range of complex problems demonstrating creativity, perseverance and provision of highly innovative solutions.
• Action and results orientated, self-motivated, resourceful and resilient with the ability to work as part of a small team.
• Excellent communications skills and emotional intelligence with a proven ability to prioritise effectively.

Technical Skills

• Proven experience and practical experience in analytical sciences including: HPLC, HPLC-MS (SQD essential, QTOF desired), GC, GC-MS FTIR, Karl-Fisher analysis, chromatography data system eg Agilent Open Lab or similar, statistical data software (eg Minitab).
• Proven experience and practical knowledge in analytical method design, development, qualification (or validation - including instrumental qualification), continuous method performance verification, and method transfer is essential.
• Experience of drug substance development.
• Experience of working in a GMP environment.
• Experience of regulatory requirements and document submission.
• Contribute to the completion of team and organisational projects and goals.
• Act as technical advisor to line manager.

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

• 25 days holiday plus public holidays
• Flexible working; core hours are 10am-3pm and we offer a flexible Friday programme, subject to completion of contractual hours.
• Paid Volunteer Time Off
• 10% company pension
• EAP service including Legal, Health and Wellbeing support
• Optional Health Insurance with BUPA
• Company Death in Service and Payment Protection Insurance
• 3 Celebratory days
• Access to platform for discounts on such as gym membership, shopping, holidays
• 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.

COMPLIANCE OBLIGATIONS:

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Employee Obligations:

• Always act with honesty and integrity.
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Always act with honesty and integrity
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

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