Aviceda Therapeutics is a private biotech company focused on the next generation of glyco-immune therapeutics (GCT's) leveraging the Glyco-Code® technology platform to address diseases of the innate immune system dysfunction.
At Aviceda, we exploit a unique family of receptors found expressed on all innate immune cells and their associated glycobiological interactions to develop transformative medicines. Combining the power of our biology with our innovative cell-based high-throughput screening (HTS) platform and proprietary nanoparticle high-affinity ligands of Siglecs (HALOS)™ technology, Aviceda was able to modulate the innate immune response specifically and profoundly.
Aviceda has assembled a world-class, cross-disciplinary team of recognized scientists, clinicians, and drug developers to tackle devastating ocular & systemic degenerative, fibrotic, neurological, and immuno-inflammatory diseases.
Aviceda's offices/lab are based in Cambridge, Massachusetts.
Job Description:
We are seeking a highly experienced and detail-oriented QA Manager to join our dynamic team. In this role, you will have the opportunity to dive into various functions of our GMP QA department, including Audit, Quality Management Systems, External Supplier Management, and Strategic Operations, all while interacting with key stakeholders. You will play a pivotal role in advancing our delivery platform by leveraging your strong background in investigational drug product development operations. Reporting directly to the Associate Director of Technology Development & Quality, you will help ensure that our clinical and pharmaceutical development efforts adhere to the highest standards of compliance and quality.
Job Responsibilities (including, but not limited to):
- Oversees all product related quality operations to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ICH requirements.
- Works closely with CMC/ Technology development group to ensure that all investigational drug substances, excipient and products are developed, manufactured and handled according to the applicable cGXP/ICH requirements.
- Develop procedures to oversee Clinical Quality functions to ensure necessary ICH/GXP-relevant regulatory requirements, SOPs, policies and guidelines. This includes but not limited to, Storage and re-packaging of Investigational product (IP) at Drug depot, Shipment of IP to clinical sites, Storage and handling of IP at clinical sites.
- Author, evaluate, and reviews deviation/nonconformance investigations and works with internal stakeholders and contract manufacturing organization(s) (CMO) to investigate and determine assignable root cause.
- Oversees the external vendor/supplier (CDMOs) auditing program to ensure the established techniques are followed and understood; maintains and controls the audit records.
- Maintains the list of approved suppliers and subcontractors.
- Perform site visits with applicable CDMOs as necessary to stay abreast with current CDMO processes, personnel, initiatives, and to ensure compliance.
- Maintains accurate and current documentation of the Quality Manual, Quality Procedures, Laboratory Operating Procedures, records, and other documents.
- Creates, revises, reviews, and approves newly written documents and document revisions.
- Addresses and controls any deviations and/or nonconformities from current procedures and techniques, determines and oversees corrective and preventive measures.
- Audits various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.).
- Reviews Quality Agreements to maintain compliance with the documents.
- Exist as a backup for other Quality Assurance functions.
- Bachelor's or Master's degree with 5 to 7 years quality related experience in the biotech industry. Degree in Pharmaceutical sciences, Health or life sciences or a related field.
- Strong communication, organizational and interpersonal skills are necessary for this role.
- Demonstrated record of working successfully with cross-functional teams including discovery, Non-clinical, Clinical operations, and CMC teams.
- Experience using statistical software for study design and data analysis.
- Ability to work in a fast-paced environment with a sense of urgency and handle multiple roles.
- Should be flexible working with different time-zones.
- Ability to travel on an infrequent basis (<20%) to support job responsibilities and commitments.
- Have knowledge of cGMPs, compendia requirements, FDA and EMA regulations.
- Have experience working with and interpreting regulatory documents such as CFRs, FDA and ICH Guidance documents is a must.
- Parenteral/sterile product development experience.
- Cold chain product development experience.
- MS. in Pharmaceutical sciences, Health or Life-Science or a related field.
Job Location: Cambridge, MA.
Job Type: Full-time, Hybrid. Preference will be given to a local candidate.
Work authorization: Work authorization in the US is required.
Aviceda Therapeutics is an equal opportunity employer offering competitive cash and stock compensation, excellent employee benefits and the opportunity for personal and professional growth in an outstanding and intellectually challenging environment.