Explore 2 engineering development program associate jobs from 1 hiring companies in Lawrence, IN, US. Filter by remote, salary, experience, and company, then open any listing to apply.

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Engineering Development Program Associate

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Engineering Development Program Associate Jobs

Eli Lilly

Onsite

Lilly

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.OverviewAt Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Position Summary The AVP is responsible for providing technical leadership to multidisciplinary teams, scientists and engineers involved in the development and commercialization of biopharmaceutical processes and products. In alignment with Lilly’s priorities, the AVP provides technical oversight and/or leads organization initiatives, evaluates and implements new capabilities/technologies and provides strategic technical direction through broad influence both internally and externally.Responsibilities<ul><li>Leads by example by providing technical leadership for specific development projects, collaborations, and component initiatives.</li><li>Maintains intimate knowledge of scientific and operational issues of specific projects, collaborations, and initiatives to support pipeline progression and resolve problems across functions.</li><li>Guides platform development associated with the clinical development and commercialization of bioproduct molecules for new Lilly products.</li><li>Owns the strategic technical agenda. Provides scientific leadership for setting the strategic direction in terms of science / technology / business and ensures implementation to support the pipeline and meet the organizational objectives.</li><li>Serves as scientific advisor, monitors project progress, ensures scientific rigor, and serves as a technical resource when issues arise.</li><li>Collaborates with technical leaders in other divisions to ensure alignment of scientific promotion expectations, objectives and work processes.</li><li> Communicates the technical successes and failures to scientific staff to influence a culture of continuous learning and improvement.</li><li>Advocates creation of strategic partnerships.</li><li>Holds leadership positions on steering teams or provides strategic oversight for partnerships and/or alliances.</li><li>Represents CM&amp;C in due diligence assessments of in-license, out-license opportunities.</li><li>Writes and/or reviews technical documents (internal reports, external disclosures, regulatory documents</li><li>Fosters and maintains expectations for compliance with quality, safety, confidentiality and corporate integrity standards/policies.</li><li>Provides technical consultations to Discovery, Regulatory, Quality, Medical, PK/PD, Toxicology, ADME, Clinical Pharmacology, and Manufacturing.</li><li>Provides career development coaching, feedback and assessment to scientists within BR&amp;D and other organizations.</li><li>Maintains awareness of regulatory requirements and ensures development strategies will meet those expectations.</li><li>Engages with the external scientific community and stays current with relevant literature.</li><li>Holds positions on external scientific advisory boards, expert committees or panels.</li><li>Shares and applies key learning with the broader organization and external scientific community.</li></ul>Basic Qualifications<ul><li>Ph.D. in chemistry, chemical engineering, analytical, biochemistry, biology , or pharmaceutical sciences and a minimum of 10 years of parenteral process and drug product development experience (alternatively, will consider skills commensurate with a PhD scientist in addition to 15 to 20 years of parenteral process and drug product development experience relating to biotechnology, biopharmaceuticals).</li><li>Experience with both early and late- phase clinical programs.</li><li>Preparation of control strategies and regulatory submissions supporting clinical development.</li></ul>Additional Preferences<ul><li>Comprehensive knowledge and understanding of (1) traditional and new modalities of parenteral drug product development (2) parenteral manufacturing and aseptic technologies, and drug product process development.</li><li>Background encompasses both innovation and technical development of oligos, protein, peptide, and gene therapies.</li><li>Technical leadership in the areas of formulation and drug delivery.</li><li>Extensive experience collaborating with key patterner functions, including discovery, and drug product delivery and device to develop innovative solutions with a patient focus in an integrated fashion.</li><li>Excellent communication, interpersonal, and leadership skills are essential. The individual must have a thorough understanding of the development process, manufacturing needs and regulatory requirements to ensure the efficient progression of projects through the development continuum to successful product registration and launch.</li></ul>  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 (<a target="_blank" href="https://careers.lilly.com/us/en/workplace-accommodation">https://careers.lilly.com/us/en/workplace-accommodation</a>) 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ&#43; Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is$237,000 - $347,600<h3></h3>Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.#WeAreLilly

Associate Vice President - Drug Product Development

Associate Vice President

PhD in chemistry, chemical engineering, analytical, biochemistry, biology, or pharmaceutical sciences; 10+ years parenteral drug product development; experience in early and late-stage programs; regulatory submissions.

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:This role is responsible for integrating Manufacturing CMC elements to support molecule commercialization and to manage the development and implementation of an integrated technical plan for commercially manufactured molecules.  This position leads a cross functional team to ensure integrated and innovative CMC plans which accelerate life changing medicines to patients throughout the Manufacturing Life Cycle with safety first and quality always.  The role is also responsible for coordinating the Global Product Assessment (GPA) for the molecule(s) which they support.  A person in this position would have a CM&amp;C focus, be expected to apply Project Management principles, provide decision-making leadership for a cross functional team, and participate in process improvement activities within Manufacturing.  Key Objectives/DeliverablesTeam Leadership<ul><li>Responsible for leading a Development and Manufacturing (central and site) team of moderate to high complexity and scope through development and execution of project plans that deliver strategic and operational objectives.  </li><li>Support the Development CM&amp;C teams in developing strategies and implementing operational plans to deliver required materials (such as API, drug product formulations, registration stability lots, clinical trial materials, etc.) as needed to support a particular project.  </li><li>Influence Development Manufacturing Technical Agenda and pre submission deliverables to enable effective transition to downstream Manufacturing plan/deliverables.</li><li>Develop and manage an integrated Post Launch Technical Agenda for assigned molecules to support launch/commercial needs, reliable supply and productivity objectives.</li><li>Responsible for the integration of the team plan to achieve Life Cycle Management objectives.</li></ul>Project Management Leadership<ul><li>Responsible for delivery of project milestones on time and within scope through the utilization of project management approaches and tools. </li><li>Document key team information and decisions and ensure project management systems are up to date.</li><li>Encourage appropriate risk taking within the team by leading risk assessments and contingency planning at the team level.</li><li>Resolve team issues with Manufacturing priorities in mind.</li><li>Ensure strategic alignment with key stakeholders.  </li><li>Support upward and cross-functional communications.</li><li>Actively track leading indicators of teams’ progress to major milestones.</li><li>Build and maintain effective teams: motivate, recognize, coach &amp; mentor team members and associates.</li><li>Gain and share learning and optimized practices within and across teams.</li></ul>Governance Facilitation and Reporting<ul><li>Responsible for facilitating Manufacturing Reviews and other governance alignment </li><li>Ensure reporting of project status, metrics, and risk.  Escalate as necessary. </li><li>Coordinate Global Product Assessments (GPAs), with Technical Stewards and Manufacturing sites, to ensure holistic review of control and capability of the manufacturing processes.</li></ul>Functional Leadership<ul><li>Mentorship of peers and team members </li><li>Support process improvement</li><li>Subject Matter Expert of a process or system</li></ul>Basic Requirements:<ul><li>Minimum 5 to 10 years’ experience in more than one Pharmaceutical Development CM&amp;C function OR Pharmaceutical Manufacturing function/site</li><li>Demonstrated leadership of cross-functional teams</li><li>Demonstrated project management experience</li><li>Demonstrated knowledge of CM&amp;C aspects of Commercialization and Commercial Manufacturing</li><li>Strong interpersonal and teamwork skills</li><li>Strong oral and written communication skills</li><li>Strong problem-solving skills, self-management and organizational skills.</li><li>BSc or MSc in Chemistry, Biology, Engineering or equivalent Scientific degree.</li></ul>Additional Preferences:<ul><li>Demonstrated knowledge of CM&amp;C aspects of Pharmaceutical Drug Development</li><li>Experience in Technical Services/Manufacturing Services, Manufacturing Operations, and/or QA/QC within Pharmaceutical Manufacturing highly desirable. </li><li>Experience with Smartsheet as a Project Management tool.</li><li>Master’s in project management, PMP Certification, or MBA preferred.</li></ul>Other Information: <ul><li>Some travel (domestic and international) may be required.  Less than 5%</li></ul>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 (<a target="_blank" href="https://careers.lilly.com/us/en/workplace-accommodation">https://careers.lilly.com/us/en/workplace-accommodation</a>) 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ&#43; Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is$117,000 - $171,600<h3></h3>Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.#WeAreLilly

Associate Director, TS/MS Manufacturing CMC Project Management

Associate Director

5-10 years in CM& C development/manufacturing; cross-functional leadership; PM experience; CM&C commercialization knowledge; strong communication; BSc/MSc in chemistry/biology/engineering.

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Engineering Development Program Associate Jobs in Lawrence, IN, US

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