Loxo@Lilly Associate Manager/Specialist, Quality Assurance - GMP in Raleigh, North Carolina
Loxo@Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo@Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
The Associate Manager/Specialist, Quality Assurance - GMP 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. The Associate Manager/Specialist, Quality Assurance – GMP will additionally 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
A minimum of 5 years of experience in Quality Assurance in an FDA regulated Biotech or Pharmaceutical setting at the Specialist level, 8 + years at the Associate 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
Strong communication skills, both written and oral
Additional locations for this role:
South San Francisco, CA
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Specialist level position could range from between $67,850 to $99,563 and $78,000 to $114,498 at the Associate Manager level 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.
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 Oncology, Inc. 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 Oncology, Inc. (“Loxo”) 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 email@example.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.