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

New

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

Associate Director, Workday Integrations & Reporting

Chewy is seeking an Associate Director, Workday Integrations & Reporting! In thi...

Location

United States , Plantation

Salary:

Not provided

Chewy

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Information Systems, Computer Science, HR Technology, or related field
or equivalent experience
8+ years of Workday technical experience, including hands-on development of integrations and advanced reporting
5+ years of leadership experience supporting enterprise-scale HR system environments, including the ability to influence throughout the organization
Proven success designing, building, and maintaining Workday integrations (Studio, PECI, Core Connectors, EIBs), as well as reporting solutions
Deep understanding of Workday data structures, security, APIs, and cross-domain dependencies
Deep technical, analytical, and problem-solving skills, as well as the skills to interpret business requirements into scalable system solutions
Experience with Agile tools and practices (JIRA, Confluence)
Customer-service mentality with a passion for improving the employee and manager experience through connected and reliable systems

Job Responsibility

Set the vision and strategy for HR integrations and reporting, ensuring alignment with business goals, compliance requirements, and Chewy’s HR technology roadmap, with an emphasis on strong governance across data flows, integrations, and reporting assets
Prioritize integration and reporting initiatives based on business value, operational impact, risk, and multi-functional dependencies, ensuring resources are allocated to the highest-impact work
Oversee the design, development, deployment, and maintenance of inbound and outbound integrations connecting Workday to enterprise systems such as payroll, benefits providers, finance platforms, UKG
Lead technical configuration, quality control, and optimization of Workday Studio, EIB, Core Connectors, PECI, Orchestrate and calculated fields to ensure accuracy, scalability, and operational stability
Manage the Workday reporting and analytics portfolio, enabling self-service dashboards, operational reporting, Report Writer, BIRT, Discovery Boards, PRISM data pipelines, and data models that enhance insights and support informed decision-making
Partner with HR, Finance, IT, and Payroll leaders to translate business needs into effective system solutions, balancing innovation with platform governance and standard methodologies
Ensure integration reliability, monitoring, and proactive issue resolution through technical standards, documentation, lifecycle management, and strong vendor partnerships
Evaluate new Workday features, assessing risks, and coordinating adoption of new integration and reporting capabilities across multiple functions
Guide and develop a high-performing team of experts skilled in Workday systems, including Integration Developers, Data Engineers, and Reporting Analysts
Champion system stability, compliance, security, and scalability across all Workday data flows and reporting structures, supported by a formal governance and standards framework

Fulltime

Director, Cold Chain Management & GDP Compliance

The Director, Cold Chain Management & Supply Chain GDP is a key role as part of ...

Location

United States

Salary:

169300.00 - 253900.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Engineering, Supply Chain, Life Sciences, or related field
10+ years of experience in pharmaceutical supply chain, with significant expertise in cold chain and GDP compliance
Proven leadership experience in a global, matrixed organization
Strong knowledge of regulatory requirements (EU GDP, FDA, WHO, etc.)
Excellent communication, stakeholder management, and problem-solving skills
Bachelor’s degree in related curriculum with a minimum of 10-12 years of experience in global trade compliance
Previous experience leading a global team
Thorough understanding of technology tools, cold chain related systems and ERP systems, with a proven record of implementing scalable compliance solutions (systems, procedures, and processes)
Strong analytical and organizational skills with the ability to anticipate problems and take proactive actions
Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk

Job Responsibility

Lead the design, qualification, and continuous improvement of cold chain systems and packaging solutions for temperature-sensitive products
Oversee monitoring of temperature-controlled logistics, including refrigerated transport, passive packaging, and storage facilities
Collaborate with internal and external stakeholders to ensure robust cold chain solutions across global markets
Drive innovation in cold chain technologies and the streamlined management and quality of associated data
Ensure global compliance with GDP regulations and internal quality standards across all distribution channels
Develop and maintain policies, procedures, and training programs related to GDP and supply chain integrity
Primary point of contact in Supply Chain for audits and inspections related to distribution and cold chain operations
Partner with Quality, Regulatory, and Logistics teams to proactively identify and mitigate compliance risks and bridge operational gaps
Direct management of a team of individual contributors across global regions
Provide strategic direction and leadership to cross-functional teams involved in cold chain and compliance activities

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Assistant Manager, Operations

Assistant Manager, Operations position at LFB, a pharmaceutical/biotech company....

Location

United States , High Point

Salary:

60000.00 USD / Year

Assessfirst

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Minimum of two (2) years relevant work experience including one (1) year experience in a supervisory position, preferably in a regulated industry
Associate’s Degree in Science or Business Management
Strong verbal and written communication skills
Must have above average problem-solving and decision-making abilities
Proficiency with computers
Must have explicit attention to detail
Must have excellent analytical skills, organization skills, and follow-up
Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Job Responsibility

Responsible for all aspects of the donor center in the absence of the Director of Center Operations Center
Ensures compliance with all federal, state, local, and company-specific rules, regulations, and practices related to the quality and safety of products, donors, and employee
Work with center leadership to develop action plans to maximize center efficiency
Responsible for all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination, and the maintenance of all personnel records
Determine the adequacy and adjust inventory levels of all goods and supplies necessary for the operation of the donor center
Construct and submit timely and accurate reports on a daily/weekly/monthly or as required basis
Develop and implement active donor recruitment advertising campaigns to improve production levels
Manage and develop talent within the donor center. Participates in the selection of new staff for the donor center
Participate in the interviewing of center staff and assists in the selection of center staff
Work collaboratively with staff, peers, and management to achieve business goals. Communicate continuously and resolves conflicts proactively

Fulltime

New

Personal Banker

Step into the role of Personal Banker at Barclays, where you'll play a pivotal r...

Location

India , Gurugram

Salary:

Not provided

Barclays

Expiration Date

Until further notice

Requirements

Resolve customer queries and issues efficiently while delivering a personalised experience across multiple communication channels
Provide exceptional customer service by handling inquiries, resolving issues, and supporting client requests accurately and on time
Collaborate with internal teams (sales, operations, risk, compliance) to meet customer needs and ensure smooth transaction execution
Ensure compliance with regulatory requirements, internal policies, and risk management standards in all customer interactions
Minimum qualification required is graduate
Strong customer service and communication skills with the ability to handle sensitive or complex information
Knowledge of banking operations, compliance, and risk management processes
International contact centre and voice experience preferred
Risk and controls
Change and transformation

Job Responsibility

Manage operations within a business area and maintain processes, risk management initiatives, and compliance with relevant regulators
Deliver personalised, compliant, and high-quality customer service across multiple digital and in-person channels while supporting efficient banking operations
Collaboration across multiple digital channels to personalise each interaction with a customer
Enhancing the bank's digital capabilities when current technology is identified as not yet ready to support
Support the collaboration of internal stakeholders including sales, operational, and risk management teams to meet client needs and expectations, so that transactions are executed accurately and on time
Support teams within the business operations function as needed, including risk management, compliance and collections
Comply with all regulatory requirements and internal policies related to customer care
To meet the needs of stakeholders/ customers through specialist advice and support
Perform prescribed activities in a timely manner and to a high standard which will impact both the role itself and surrounding roles
Likely to have responsibility for specific processes within a team

What we offer

Wellness rooms
On-site cafeterias
Fitness centers
Tech-equipped workstations
Hybrid working
Structured approach to hybrid working with fixed 'anchor' days
Supportive and inclusive culture and environment
Commitment to flexible working arrangements

Fulltime

Associate Director, Quality Control – Analytical Sciences

Apogee Therapeutics

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 13, 2026

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