Principal Scientist, TSMS Small Molecule Synthesis - ADN RAMP Team

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 64,000 - 168,000; Full time

Job summary

An established industry player is seeking a Principal Scientist to lead small molecule synthesis for new site start-ups. This role involves providing technical leadership, managing relationships, and ensuring effective technology transfers. The ideal candidate will have a strong background in pharmaceutical manufacturing, excellent analytical and problem-solving skills, and the ability to coach and mentor others. Join a dynamic team dedicated to improving patient outcomes while enjoying opportunities for professional growth and development in a collaborative environment.

Qualifications

• 5+ years in pharmaceutical drug substance manufacturing.
• Deep understanding of product development and manufacturing control strategy.

Responsibilities

• Provide technical leadership during new site start-ups and process validation.
• Manage relationships and resolve technical issues at manufacturing sites.
• Collaborate across disciplines for process performance improvements.

Skills

Analytical Skills

Problem-Solving

Communication Skills

Collaborative Skills

Technical Knowledge of Manufacturing Science

Coaching Ability

Influencing Without Authority

Clarifying Complex Issues

Education

PhD in Chemistry

MSc in Chemistry or Related Science

Job description

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Principal Scientist, TSMS Small Molecule Synthesis - ADN RAMP Team

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Brand Description:

The Lilly API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production, however additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates.

The ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly’s vision of serving more patients.

Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration – and development of the local technical and operational teams to be ready for full operation.

The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director.

Key Responsibilities:

Responsible for depth of Small Molecule synthesis knowledge transfer and manufacturing support during Small Molecule New Site Start-ups and process validation execution. Key responsibilities include:

• Provide technical leadership support to the new site TSMS team for technology transfers from sending manufacturing sites or Development (internal or external).
• Leverage prior experience to anticipate commercial manufacturing challenges for new small molecule/synthetic active pharmaceutical ingredients (APIs) through new site start-ups and scale increases. Work with the local TSMS team to mitigate such challenges.
• Work across the Development organization and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs of the new site.
• Establish strong working relationships with Lilly’s Small Molecule development organization (SMDD) to ensure development knowledge is well established and available to support the new site tech transfer.
• Establish depth of understanding of control strategy (CS) of molecules being transferred and work with the site TSMS team to translate this control strategy into unit operation requirements to ensure robust and right first time technology transfer to new facilities.
• Have a depth of understanding of the analytical control strategy of the product being transferred that allows critical technical review of the implementation of the analytical CS at the new site, including process analytical technology for on line and at line monitoring and control.
• Manage internal and external relationships in cases where new manufacturing facilities are receiving materials from External Manufacturing teams - providing additional technical support/guidance for external manufacturing as needed.
• Lead resolution of technical issues including those related to control strategy and operational challenges at the site.
• Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
• Work closely with Development and Global Regulatory teams to author/review regulatory submission documents and subsequently respond to Information Requests/Regulatory Questions.
• Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation.
• Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.
• Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles.

Basic Requirements:

• PhD or MSc in Chemistry or related science field with 5+ years’ experience in pharmaceutical drug substance manufacturing.
• Deep technical interest and understanding of product development and manufacturing control strategy.

Additional Skills/Preferences:

• Excellent verbal and written communications skills.
• Strong analytical and problem-solving skills.
• Collaborative skills with operations, process engineering, QCL and other process team members.
• Technical knowledge of manufacturing science.
• Ability to coach others.
• Ability to influence without authority.
• Ability to clarify and simplify complex issues.
• Strong trust building with peers and leaders.
• Willing to work off-shift hours as needed to support project milestones and training of new employees.

Other Information:

The ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $167,200.