Manager-Analytical & Data Verification

Amgen Inc. (IR); Hyderabad; On-site; INR 3,000,000 - 5,200,000; Full time

Job summary

Amgen is seeking a Manager Stability in Hyderabad to oversee stability data programs, support GMP compliance, and collaborate with PQTs globally to ensure data integrity across products. You will lead staff, coordinate time-sensitive activities, and drive standardization of data processes.

The role requires a Master's in a related field with 10+ years in Quality or scientific roles, plus strong communication and cross-functional collaboration skills.

Qualifications

• Master's degree in chemistry, biochemistry, biology, or related pharmaceutical sciences.
• 10+ years of Quality, Operations, or scientific experience.
• Experience managing data in GMP environments and leading cross-functional teams.

Responsibilities

• Directly supervise Quality staff supporting Product Quality Teams and regulatory submissions.
• Manage staff training and coordinate assignments across multiple teams.
• Author, revise, review, and approve GMP documents and work instructions.

Skills

Team leadership

GMP data management

Chromatography

Regulatory knowledge

Communication

Cross-functional collaboration

Problem solving

Attention to detail

Project coordination

Education

Master's degree in chemistry/biochemistry/biology

Tools

LIMS

Veeva

Spotfire

SHINY

Job description

Career Category Quality Job Description

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The Stability function is part of the Amgen Product Quality organization, providing governance and management of lean, harmonized, and compliant Stability data packages for all of Amgen’s products. In this team-based role, Manager Stability will collaborate with Product Quality Teams (PQTs), supporting specialist teams, and Global stability teams to ensure the design, management, maintenance, and data analysis of a product’s stability program support GMP compliance and meet the Market Authorization commitments. In this management role you will provide critical support to PQTs through management of activities and staff supporting different programs for late-stage clinical and commercial products. In this team-oriented manager role, you will serve as a subject matter expert of GMP data management strategy, directly adding to the success of PQTs by ensuring support for the product Quality strategies. In this role, you will be working closely with diverse functional groups including Supply Chain, Manufacturing, Global CMC Statistics, External Supplier Quality, Quality Control, Regulatory, Quality Assurance, external providers, and other departments on a variety of activities. Such activities include managing data standardization activities, Chromatographic overlays, data verification and, where warranted, investigations, regulatory submissions and support for inspections across the Amgen manufacturing and testing network.

Roles & Responsibilities

• Directly supervise Quality staff supporting Product Quality Teams and activities enabling regulatory submissions
• Adeptly manage staff training and independently coordinate staff assignments supporting time-sensitive activities across multiple teams
• Author, revise, review, and approve technical documents in GMP Quality systems, including but not limited to data reports, Standard Operating Procedures, and Work Instructions
• Work closely with the global Product Quality organization to drive standardization of data, Chromatographic overlays and data verification activities
• Lead continuous improvement projects that may be global or local in scope
• Own, manage, and participate in deviations, CAPAs, and cross functional investigations
• Communicate and collaborate with cross-functional teams across multiple sites and time zones to coordinate stability study starts and sample requests
• Participate in audits and inspections across multiple sites
• Mentor and train staff, as required

Basic Qualifications and Experience

Master's degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and above 10 years of Quality, Operations, Scientific experience.

Functional Skills

Must-Have Skills

• Experience and expertise in managing teams and motivating staff to deliver high quality results and adhere to project timelines using digital GMP Quality systems
• Demonstrated proficiency and knowledge in biologics manufacturing processes including analytical methods, cGMP, and international regulatory expectations
• Demonstrated proficiency is oral and written communication of complex information
• Ability to build and maintain cross-functional relationships and strong partnerships through written and verbal communication skills
• Exceptional attention to detail and accuracy in all deliverables
• Strong scientific data management and organization skills
• Expertise with chromatography systems, Laboratory Information Management Systems
• Expertise in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., MS Teams)
• Effective communication, critical thinking and problem solving

Good-to-Have Skills

• Experience working virtually on a cross-functional team in a matrix environment across multiple time zones
• Expertise in computer applications such as Veeva, Spotfire, SHINY
• Expertise in MS Office (Word, Excel, PowerPoint, MS Teams)

Soft Skills

• Analytical and problem-solving skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen