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Loxo@Lilly Senior Associate/Manager, Quality Assurance - GMP in Augusta, Maine

About Loxo@Lilly:

Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.

This individual will work closely with Loxo@Lilly Regulatory, Drug Supply, CMC, and the associated contract organizations in support of activities associated with GMP manufacturing and release. Additionally, will provide Quality Systems support, as required.

Roles and Responsibilities of the Position:

  • Work closely with Loxo@Lilly QA, CMC, Regulatory, Drug Supply, and CMO colleagues through all phases of drug development, particularly early phase to ensure compliance and timeliness of GMP work, including:

  • Batch record review (Executed and Master) for all phases of manufacturing (drug substance, drug product, packaging, labeling, and associated intermediates)

  • Final disposition of finished product for clinical use, including country-specific release and collaboration with Qualified Persons (QPs)

  • Authoring and review of deviations, CAPAs, and change controls

  • Investigation of product complaints

  • Quality review of analytical documentation including: analytical methods; validation protocols and reports; specifications; and stability protocols, reports, and expiry extensions

  • QC of IMPD/IND CMC sections

  • Review and approval of clinical product labels

  • Authoring/ revision of SOPs

  • Implementation of process improvements

  • Ensuring that GMP work at Loxo and contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.

  • Participation on project teams and sub-teams as needed and assigned

  • Additional tasks as required.

Required Qualifications and Preferred Background:

  • BA/BS in science or engineering required along with experience in Quality Assurance in an FDA regulated Biotech or Pharmaceutical setting; a minimum of 5 years of experience at the Senior Associate level and a minimum of 8+ years at the Manager level

  • Experience in Batch Review and Release for clinical phase products

  • Experience authoring and reviewing Deviations, CAPAs, and Change Controls

  • Experience working with solid oral dosage products and/or Biologics

  • Working knowledge of cGMP’s (CFR/ICH) and applicable international regulations/guidelines

  • Experience working with Contract Manufacturing Organizations

  • Strong understanding of GMP requirements for early phase drug development

  • Attention to detail and accuracy of work

  • Ability to work in a fast-paced environment to meet tight deadlines

  • Ability to problem solve and implement process improvements

  • Ability to serve as an active participant and contributor in cross-functional meetings

  • Ability to escalate issues when necessary

  • Ability to work in a cross-functional environment

  • Ability to work in a virtual manufacturing environment

  • Demonstrated ability to work well with other accomplished professionals

  • Willing collaborator

  • Strong communication skills, both written and oral

Additional locations for this role:

  • Remote Based

  • Louisville, CO

  • Stamford, CT

  • South San Francisco, CA

Loxo@Lilly currently anticipates that the base salary for the Senior Associate position could range from between $75,000 to $110,000 and that the Manager level position could range from between $90,000 to $132,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described.

Physical Demands/ Travel:

The physical demands of this job are consistent with light office duties .

Domestic and International Travel 10-15%

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in an office, manufacturing facility.

The work environment characteristics described here are representative of those an employee encounters while performing the

essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo@Lilly (Eli Lilly and Company) is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

Loxo@Lilly (Eli Lilly and Company) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email loxoaccommodation@loxooncology.com for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.

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