Senior Associate/Manager, Quality Assurance - GMP
Company: Loxo@Lilly
Location: Saint Paul
Posted on: January 25, 2023
Job Description:
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.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 cGMPs (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 oralAdditional
locations for this role:
- Remote Based
- Louisville, CO
- Stamford, CT
- South San Francisco, CALoxo@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 candidates 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 positions work environment is in an office,
manufacturing facility.The work environment characteristics
described here are representative of those an employee encounters
while performing theessential 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.
Keywords: Loxo@Lilly, St. Paul , Senior Associate/Manager, Quality Assurance - GMP, Executive , Saint Paul, Minnesota
Didn't find what you're looking for? Search again!
Loading more jobs...