Director, Process Development - Drug Substance

Amgen Technology; Hyderabad; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Amgen Technology in Hyderabad seeks a senior leader to establish and head the Drug Substance Technologies (DST) team within the Process Development organization. You will build capabilities, operating model, and cross-site partnerships to advance drug substance deliverables, ensuring high-quality outcomes and alignment with Amgen values.

You will partner with DST leadership and site stakeholders to define capabilities, resource the team, and drive innovative digital tools and process monitoring

Qualifications

• Doctorate degree with 8+ years of drug substance biotech experience
• Masters with 15+ years of drug substance biotech experience
• Bachelor's with 20 years of drug substance biotech experience and leadership experience
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Responsibilities

• Report dotted line to DST leadership, leading a team at AIN focused on advancing drug substance deliverables
• Work with functional partners and other Amgen sites to define roles, hire and build teams, and implement new processes
• Build and lead a new DST team at AIN with capabilities across technical documentation, regulatory authoring and support, data analytics, automation/digital tools, and process monitoring
• Create strong communication channels with DST teams across Amgen sites to enable knowledge sharing and networking
• Work with cross-functional teams to establish and improve digital tools as voice of customer
• Manage the team for Drug Substance Technologies at AIN to ensure timely completion of goals
• Set project timelines and priorities for key initiatives and team activities
• Lead and develop the team, providing staff supervision and ongoing coaching
• Strategically plan, analyze, and manage resources including budget, contractors, staff
• Act on performance metrics and drive continuous improvement with escalation when needed
• Partner to establish operating model, governance, and engagement framework for the AIN DST team
• Translate business, technical, and regulatory needs into team capabilities and execution plans

Skills

Leadership

Team Building

Project Management

Agile Methods

Data Analytics

Automation / AI

Communication

Cross-functional

Strategic Planning

Budget & Resources

Education

Doctorate in Biotech

Master's in Biotech

Bachelor's in Biotech

Job description

Job Summary

Lets do this. Lets change the world. In this vital role you will lead adiverse team within our Process Development organization,maintaining accountability for its daily operationswith a focus on Drug Substance Technologies (DST). You willbuild a new team, creating the capabilities, operating model, and cross-site partnerships needed to advance drug substance deliverables for Amgen products. You will ensure a high level of quality in the work performed. You will partner with key internal stakeholders tobuild this new organization, define the required capabilities, and resource it with ateam of qualified personnel who have the education, experience, and training needed to perform the work inalignment with Amgen values.

Responsibilities

• Report dotted line toDST leadership, leading a teamat AIN thatis focused on advancingdrug substance deliverables for all Amgen products
• Work with functional partnerswithin AIN as well as other Amgen sites and teamsto define roles and responsibilities, hire and build new teamsand implement new processes
• Build and lead a new DST team at AIN with capabilities across technical documentation, regulatory authoring and support, data analytics, automation/digital tools, and process monitoring
• Creation of strong communication channels with existing DST teamsacross the Amgen sitesto establish and driveknowledge sharing, learning and networking
• Work with cross-functional teams to establish and improve digital tools as voice of customer
• Manage the team for Drug Substance Technologiesat AIN to ensure timely completion of goals and objectives
• Set project timelines and priorities for key initiatives and/or team activities
• Lead and developtheteam, providing staff member supervision and on-going coaching
• Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc.
• Actupon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed
• Partner to establish the operating model, governance, and engagement framework for the AIN DST team in partnership with DST leadership and AIN site stakeholders
• Translate business, technical, and regulatory needs into team capabilities, priorities, and execution plans

What youwill do

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 8 years ofdrug substance biotechexperienceOR
• Masters degree and 15 years ofdrug substance biotechexperience OR
• Bachelors degree and 20 years ofdrug substance biotechexperienceAND
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• 14+ years ofdrug substance process development ormanufacturing experience in biotech or pharmaceutical industry
• Advanced Degree in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline
• Knowledge of cGMP regulations (FDA, EMEA, Health Canada)
• Working knowledge of applicable drug substance manufacturing/ testing processes (process development, process validation, commercial manufacturing)
• Experience applying automation, artificial intelligence, machine learning, or large language model-enabled tools in a compliant enterprise environment.
• Knowledge ofstatistics,data analyticstools and methods
• Knowledge ofproject management toolsand Agile methodologies
• Strong leadership skillswiththe abilitytobuild new teams and implement new processes
• Demonstrated ability leading and coachingcross-functional teams, consistentlydeliveron-time, and with high-quality results
• Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership, includingcommunicatinglevel of risk, urgency, or impact to the business
• Ability to operate in an internationalmatrix or team environment with site, functional, and executive leadership
• Ability to flex working hours to maximize interactions with global teams