BioSpace
Director - Engineering - Formulations Development - BR&D
BioSpace, Indianapolis, Indiana, us, 46262
Overview
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Director - Engineering - Formulations Development - BR&D
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BioSpace . 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 work to discover and bring life-changing medicines to those who need them. We’re looking for people who are determined to make life better for people around the world. Organization Overview Due to a strategic commitment to the growth of biotherapeutics within the Lilly portfolio, multiple opportunities are currently available within the Bioproduct Research and Development (BR&D) drug product organization. This group develops and commercializes parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also investing in genetic medicines including oligonucleotides and antibody conjugates (ADC and AOC). Delivery platforms include tissue-specific targeting, lipid nanoparticles, and AAV and other non-viral vectors. We are seeking highly motivated and technically creative professionals with experience in developing and commercializing parenteral drug products through various stages of clinical development. If you are interested in building innovative platforms for new and novel therapeutic modalities and leading a strong group of scientists in formulation and drug delivery, consider joining our diverse team. Responsibilities
Visible leadership within the formulation development engineering group Represent Drug Product team in CM&C teams and cross-functional interface meetings Lead process development of Lilly’s expansive parenteral portfolio Define and develop manufacturing processes, including process performance and capability criteria, for bioproduct dosage forms intended for the commercial market Develop manufacturing process control strategies for clinical and commercial products Develop processes for use in clinical trial manufacturing Lead the preparation of the CMC portion of IND/CTA/BLA/NDA Build process capabilities for lab scale, early phase clinical scale, and scale-up technologies for novel parenteral drug products and other complex formulations Instill a fundamental engineering mindset into process development activities Lead tech transfer of processes and formulations to clinical manufacturing sites across scales and sites Lead the design, execution and interpretation of experiments to optimize DP manufacturing processes Identify and evaluate cutting-edge process technologies for complex or unstable bioproducts and integrate relevant technologies into the Lilly parenteral development lexicon Demonstrate a commitment to industry leadership through publications, presentations, and trade group involvement Coaching, training and performance management of personnel (primarily direct reports) Collaborate with manufacturing technical service, corporate engineering technology center, and Indy parenteral manufacturing to define manufacturing and validation strategies Provide technical guidance for ongoing support of marketed products manufacturing Promote a Quality by Design mindset to accelerate development for newer assets Develop advanced mathematical methods and computational tools for process modeling and equipment development Lead manufacturing and evaluation of clinical trial formulations to determine viability of commercial platforms Basic Qualifications / Requirements PhD in Chemical Engineering or related field 7 to 15 years of experience in the pharmaceutical or biotech industry in developing parenteral drug product manufacturing process technologies Experience supervising scientists and engineers Additional Skills and Preferences Extensive experience in parenteral drug product process development Deep understanding of parenteral manufacturing processes and stability issues for proteins, peptides or genomic medicines Creativity, imagination, and ability to translate ideas into practical processes Experience with manufacturing process development of parenteral drug products including oligos, proteins, peptides, viral or cell therapeutics Understanding of analytical techniques for proteinaceous materials and/or oligonucleotides, AAVs Technical expertise in formulation and drug delivery Advanced computer skills (computational modeling, data analysis, statistics) Excellent oral and written communication skills Proven experience in team management and cross-functional collaboration Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form on our site. Lilly is an equal opportunity 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 candidate education, experience, skills, and location. The anticipated wage for this position is $142,500 - $253,000. Full-time employees may be eligible for a company bonus and comprehensive benefits as described by Lilly’s guidelines. #WeAreLilly
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Join to apply for the
Director - Engineering - Formulations Development - BR&D
role at
BioSpace . 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 work to discover and bring life-changing medicines to those who need them. We’re looking for people who are determined to make life better for people around the world. Organization Overview Due to a strategic commitment to the growth of biotherapeutics within the Lilly portfolio, multiple opportunities are currently available within the Bioproduct Research and Development (BR&D) drug product organization. This group develops and commercializes parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also investing in genetic medicines including oligonucleotides and antibody conjugates (ADC and AOC). Delivery platforms include tissue-specific targeting, lipid nanoparticles, and AAV and other non-viral vectors. We are seeking highly motivated and technically creative professionals with experience in developing and commercializing parenteral drug products through various stages of clinical development. If you are interested in building innovative platforms for new and novel therapeutic modalities and leading a strong group of scientists in formulation and drug delivery, consider joining our diverse team. Responsibilities
Visible leadership within the formulation development engineering group Represent Drug Product team in CM&C teams and cross-functional interface meetings Lead process development of Lilly’s expansive parenteral portfolio Define and develop manufacturing processes, including process performance and capability criteria, for bioproduct dosage forms intended for the commercial market Develop manufacturing process control strategies for clinical and commercial products Develop processes for use in clinical trial manufacturing Lead the preparation of the CMC portion of IND/CTA/BLA/NDA Build process capabilities for lab scale, early phase clinical scale, and scale-up technologies for novel parenteral drug products and other complex formulations Instill a fundamental engineering mindset into process development activities Lead tech transfer of processes and formulations to clinical manufacturing sites across scales and sites Lead the design, execution and interpretation of experiments to optimize DP manufacturing processes Identify and evaluate cutting-edge process technologies for complex or unstable bioproducts and integrate relevant technologies into the Lilly parenteral development lexicon Demonstrate a commitment to industry leadership through publications, presentations, and trade group involvement Coaching, training and performance management of personnel (primarily direct reports) Collaborate with manufacturing technical service, corporate engineering technology center, and Indy parenteral manufacturing to define manufacturing and validation strategies Provide technical guidance for ongoing support of marketed products manufacturing Promote a Quality by Design mindset to accelerate development for newer assets Develop advanced mathematical methods and computational tools for process modeling and equipment development Lead manufacturing and evaluation of clinical trial formulations to determine viability of commercial platforms Basic Qualifications / Requirements PhD in Chemical Engineering or related field 7 to 15 years of experience in the pharmaceutical or biotech industry in developing parenteral drug product manufacturing process technologies Experience supervising scientists and engineers Additional Skills and Preferences Extensive experience in parenteral drug product process development Deep understanding of parenteral manufacturing processes and stability issues for proteins, peptides or genomic medicines Creativity, imagination, and ability to translate ideas into practical processes Experience with manufacturing process development of parenteral drug products including oligos, proteins, peptides, viral or cell therapeutics Understanding of analytical techniques for proteinaceous materials and/or oligonucleotides, AAVs Technical expertise in formulation and drug delivery Advanced computer skills (computational modeling, data analysis, statistics) Excellent oral and written communication skills Proven experience in team management and cross-functional collaboration Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form on our site. Lilly is an equal opportunity 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 candidate education, experience, skills, and location. The anticipated wage for this position is $142,500 - $253,000. Full-time employees may be eligible for a company bonus and comprehensive benefits as described by Lilly’s guidelines. #WeAreLilly
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