Indiana Staffing
Associate Director Technical Services and Manufacturing Science Indy API
Indiana Staffing, Indianapolis, Indiana, us, 46262
Associate Director TS /MS IAPI
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. Summary: The Associate Director TS /MS IAPI is primarily responsible for the productivity and development of the employees with the purpose of ensuring the reliable and compliant manufacturing of Active Pharmaceutical Ingredient (API). Additionally, partner to influence and implement within the TS /MS organization and across functional disciplines to support the TS /MS technical agenda, IAPI Business Plan priorities and GMP Quality Plan objectives. This person will work closely with the site management and other leaders at the site to ensure the highest standards of quality are being met through best-in-class processes, equipment, and people. They will also be responsible for leading continuous improvement efforts across the site and ensuring that we have robust technical capabilities to support ongoing commercial products. The ideal candidate will have experience working in a large pharmaceutical or biotech environment and possess a strong understanding of cGMPs, regulatory requirements, and other relevant compliance matters. Responsibilities: Leading /mentoring a technical staff and understanding of protein chemistry as it relates to API manufacturing. Provide guidance on time management and priorities for direct reports. Time management skills to assist in the productive completion of daily activities, implementation of technical projects and balance new technical priorities. Key position responsibility is to address and document GMP compliance issues and development /execution of process /cleaning validation plans. Therefore, the position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate /industry standards for process /cleaning validation. Influence and implement the network technical agenda within a multi-discipline technical environment. Provide technical leadership for the preparation of the periodic product reviews and act as the primary technical representative in a cross-functional setting on Technical Review Board (TRB) and /or Deviation Review Board (DRB). Work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plan, and quality objectives. Work closely with the site management and other leaders to ensure the site is operating safely and efficiently. Develop and maintain relationships with key external stakeholders such as regulators, suppliers, and customers. Ensure compliance with all applicable regulations related to GxPs (Good Practices), environmental health and safety, and security. Basic Qualifications: Bachelor's degree or equivalent in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, or Bio /Chemical Engineering are minimum requirements. 8+ years of relevant experience in a manufacturing environment. Strong knowledge of cGMPs, FDA regulations, and other relevant compliance matters. Additional Preferences: Excellent communication skills, both written and verbal. Ability to influence and collaborate effectively with senior leaders and cross-functional teams. Demonstrated ability to lead change and drive results in a fast-paced, dynamic environment. Commitment to safety, quality, and operational excellence. Teamwork and interpersonal skills, technical, leadership, administrative, organizational, independent decision making, multi-tasking, and problem solving. This role is located onsite in Indianapolis, IN with the ability to work from home up to 4 days per month. 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. 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. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800.
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. Summary: The Associate Director TS /MS IAPI is primarily responsible for the productivity and development of the employees with the purpose of ensuring the reliable and compliant manufacturing of Active Pharmaceutical Ingredient (API). Additionally, partner to influence and implement within the TS /MS organization and across functional disciplines to support the TS /MS technical agenda, IAPI Business Plan priorities and GMP Quality Plan objectives. This person will work closely with the site management and other leaders at the site to ensure the highest standards of quality are being met through best-in-class processes, equipment, and people. They will also be responsible for leading continuous improvement efforts across the site and ensuring that we have robust technical capabilities to support ongoing commercial products. The ideal candidate will have experience working in a large pharmaceutical or biotech environment and possess a strong understanding of cGMPs, regulatory requirements, and other relevant compliance matters. Responsibilities: Leading /mentoring a technical staff and understanding of protein chemistry as it relates to API manufacturing. Provide guidance on time management and priorities for direct reports. Time management skills to assist in the productive completion of daily activities, implementation of technical projects and balance new technical priorities. Key position responsibility is to address and document GMP compliance issues and development /execution of process /cleaning validation plans. Therefore, the position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate /industry standards for process /cleaning validation. Influence and implement the network technical agenda within a multi-discipline technical environment. Provide technical leadership for the preparation of the periodic product reviews and act as the primary technical representative in a cross-functional setting on Technical Review Board (TRB) and /or Deviation Review Board (DRB). Work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plan, and quality objectives. Work closely with the site management and other leaders to ensure the site is operating safely and efficiently. Develop and maintain relationships with key external stakeholders such as regulators, suppliers, and customers. Ensure compliance with all applicable regulations related to GxPs (Good Practices), environmental health and safety, and security. Basic Qualifications: Bachelor's degree or equivalent in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, or Bio /Chemical Engineering are minimum requirements. 8+ years of relevant experience in a manufacturing environment. Strong knowledge of cGMPs, FDA regulations, and other relevant compliance matters. Additional Preferences: Excellent communication skills, both written and verbal. Ability to influence and collaborate effectively with senior leaders and cross-functional teams. Demonstrated ability to lead change and drive results in a fast-paced, dynamic environment. Commitment to safety, quality, and operational excellence. Teamwork and interpersonal skills, technical, leadership, administrative, organizational, independent decision making, multi-tasking, and problem solving. This role is located onsite in Indianapolis, IN with the ability to work from home up to 4 days per month. 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. 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. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800.