Principal Analytical QA Specialist, Drug Substance

1 мес. назад

USALeadRemote

gmpquality assurancevalidationbatch dispositionstability testing

Provide Quality Assurance oversight of GMP manufacturing and related activities for veterinary pharmaceutical products.

Обязанности

We’re seeking an experienced Principal Analytical QA Specialist, Drug Substance to provide Quality Assurance oversight of GMP manufacturing, release, stability, validation, and lifecycle management activities supporting the development and commercialization of Loyal's veterinary pharmaceutical products. Operating within Loyal's fully outsourced manufacturing network, the position supports batch disposition of active pharmaceutical ingredient (API) / drug substance, drug product, packaging and labeling through review and approval of protocols, reports, analytical methods, and associated GMP documentation.
The role works collaboratively with Technical Operations and Analytical Development / Quality Control to ensure that the manufacture and laboratory analysis of drug substance, drug product, packaging & labeling of finished drug product conforms with cGMPs, VICH and global regulatory requirements. This position also partners with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.

Требования

B.S./M.S. degree in in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field) 
Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles.
Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products
In-depth working knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems.
Experience managing CDMOs and collaborating effectively across cross-functional teams.
Capable of working successfully in a team/matrix environment and independently, as required.
Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
Ability to convey both written and verbal information effectively and efficiently.
Demonstrated ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail.
Willingness to travel (10%).

Будет плюсом

Other Compliance or Regulatory certifications (e.g., RAC, ASQ) a plus.
Experience auditing suppliers, CDMOs, and CTLs.
Experience with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems.
Experience in small molecule pharmaceutical development, routine analytical testing for solid oral dosage forms, and/or veterinary drug products preferred.
Experience with international regulatory environments (EU, Canada, etc.) a plus
Salary Range: $150,000 - $190,000

Условия

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends 🎉
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
Competitive salary
Company equity options grant for new hires
Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.

Другое

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.
We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year.
Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love.
Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase.
Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs supporting drug substance and drug product development.
Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations.
Review and approve validation protocols, raw data, and reports (for test method, process, cleaning, etc.).
Manage the batch release program by reviewing executed documentation, raw data, quality events (change controls, deviations, CAPAs, OOS/OOT investigations, risk assessments) and product disposition decisions.
Review and approve master and executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation ensuring batches are compliant with cGMP requirements.
Lead or support quality event resolution investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure.
Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review (APR) and product quality processes, Field Alert Report (FAR), product withdrawal, and product recall process.
Perform data integrity and compliance assessments including review against source documentation for regulatory submissions.
Maintain effective communication with Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) to ensure Quality objectives are achieved in accordance with project timelines.
Maintain awareness of evolving veterinary pharmaceutical regulations and ensure compliance strategies are updated accordingly
Strong technical judgment and problem-solving 
Attention to detail and commitment to quality 
Excellent written and verbal communication 
Ability to influence cross-functional teams and external partners 
Effective project and time management 
Collaborative mindset with a continuous improvement focus
Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure.
We lean into combining disciplines, expertise, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
Titles do not determine who has a voice. We push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat.
Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission.
We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions.
Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously.