Associate Director, Quality Control – Analytical Sciences Job at Apogee Therapeutics

In-Business QA, Business Risk Credit Analyst

The role involves quality assurance relating to Wholesale Credit Risk processes,...

Location

India , Mumbai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Relevant work experience in Risk & Control function focusing on Wholesale Credit Risk
Hands on experience of Data Science / Data Analytics
Deep understanding of control framework in the banks
Experience in BCBS 239 is highly desirable
Python is essential
Tableau and SQL are added advantages
Consistently demonstrates clear and concise written and verbal communication skills
Effective organizational influencing skills required
Excellent problem-solving skills
Ability to see the big picture with high attention to critical details

Job Responsibility

Support the In-Business Quality Assurance Head of Data Analytics to set the global strategy for and lead the implementation and ongoing delivery of a robust Data analytics and testing program for the Quality Assurance function as it relates to Wholesale Credit Risk (WCR) data governance
Provide effective challenge on the design and operation of the data and credit processes within ICM and report any identified gaps and concerns through quarterly reports published to ICM senior management
Ability to query and clean complex datasets from multiple sources to funnel into advanced statistical analysis
Hands-on experience in designing, planning, prototyping, productionizing, deploying, maintaining, and documenting reliable and scalable data science solution
Perform design and operational effectiveness assessments of various business processes within Wholesale Credit Risk
Participate and independently lead Quality Assurance Reviews (QAR) covering data-relevant aspects
Read policies, standards, and procedures to understand key pillars, responsibilities, associated risks, and expected controls for the business process(es) in scope
Lead data discovery to identify data lineage and controls for the defined business process in scope
Evaluate findings identified through the Quality Assurance process, determine materiality, and partner with business teams to drive sustainable remediation
Collaborate within IBQA teams and with QA Directors and provide them with analytics insights

Fulltime

Associate Director, Analytical Development and Quality Control

The Associate Director, Analytical Development and Quality Control will support ...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience, or 5+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, dissolution, along with extractables and leachable analysis
Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
Hands-on experience supporting early- and late-stage CMC development, stability programs, and specification setting
Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls
Strong track record of working with CROs/CMOs and managing external analytical/testing activities
Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)
Demonstrated leadership ability with experience mentoring and developing scientific staff
Strong communication, cross-functional collaboration, and project-management skills
Innovative team-player with high energy for our dynamic company environment

Job Responsibility

Support analytical development and QC activities related to characterization of drug substances and drug products from early-stage clinical development through commercialization
Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results
Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale
Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases
Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior
Support comparability assessments for process changes, analytical method updates, or site transfers
Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Laboratory Operations Supervisor

Responsible for the operation of their laboratory area in accordance with establ...

Location

United States , Social Circle

Salary:

86500.00 - 135960.00 USD / Year

BioLife Plasma Services

Expiration Date

Until further notice

Requirements

Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical, or medical laboratory science, or medical technology, or nursing from an accredited institution
Or have earned an associate degree in a chemical, biological, clinical, or medical laboratory science, or medical laboratory technology, or nursing from an accredited institution
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records
Demonstrate work history of above-average performance and attendance
Excellent interpersonal skills and communication skills, including written, verbal, and oral presentations
Result-oriented with the ability to adapt to changing priorities
Attention to detail and organizational skills with analytical and problem-solving skills
Proficiency in the use of personal computers and software programs, including Microsoft Word, Excel, and PowerPoint
Ability to stand up for 6-8 hours
Ability to lift, carry, and pull up to twenty-five (25) pounds

Job Responsibility

Provides day-to-day supervision of all laboratory operations and moderate or high complexity testing performance in their laboratory area
Functions as a supervisor for testing personnel performing high and moderate complexity testing
Organize and prioritize workloads and assignments in conjunction with donor center requirements
Responsible for maintaining reagent and consumable inventory
Performs annual employee performance reviews and employee counseling
Performs and reviews pre-analytical staff training and competency assessments
Ensures proper training is received under the oversight of the Operations Manager and the CLIA Laboratory Director
Provides technical assistance to staff, operations, and donor centers in laboratory-related issues
Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone, or electronic consultation to resolve technical problems
Performs NCMR, ENC, and CAPA functions

What we offer

Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time per calendar year
Up to 120 hours of paid vacation (new hires)

Fulltime

Associate Director, QC Manufacturing Support

We are seeking an Associate Director, QC Manufacturing Support to provide GMP ra...

Location

United States

Salary:

160000.00 - 180000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.)
10+ years of biotech industry experience in QC operations or analytical support roles
At least 6 years demonstrated experience supporting a GMP raw materials testing program
Understanding of analytical techniques relevant to monoclonal antibody testing
Experience in relationship management with external analytical test sites
Ability to effectively prioritize and manage multiple projects
Understanding of quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing
Excellent communication skills
able to collaborate effectively across multidisciplinary teams
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Job Responsibility

Author internal raw materials testing specifications, specifically for non-compendial raw materials
Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation
Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites
Review and assess impact of vendor change notifications related to GMP raw materials
partner with internal and external stakeholders to development plans for material changes with major impact
Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing
may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management
Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required
Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime