Senior Technical Manager

Job description

The Project Manager will coordinate the initial cross-functional assessment of nitrosamine risk for biotherapeutic products, including proteins and cell and gene therapies. The immediate objective is to determine whether existing paper-based risk assessments and supporting documentation remain adequate against current regulatory expectations, and to define any evidence gaps, potential follow-up work, and an indicative scope and resource estimate. This is an assessment-first role; confirmatory testing or remediation should not be assumed. Key Responsibilities Stakeholder coordination: Partner with the designated Biotherapeutics leads to identify and engage the relevant drug substance, drug product, MSAT Material Sciences, and R&D Material Sciences SMEs, keeping outreach focused on the assessment. • Assessment workplan: Establish a focused workplan with clear owners, milestones, decisions, and dependencies that leads to an initial scope and resource estimate, aligned with the existing Synthetics nitrosamine program. • Evidence review: Under SME direction, coordinate the review of existing biotherapeutics nitrosamine risk evaluations, underlying assumptions, and supporting evidence, including material, process, water, packaging, and storage inputs. • Technical discussions: Arrange targeted technical discussions and document decisions, open questions, evidence requests, and follow-up actions. Facilitate comparison of assumed biotherapeutics nitrosamine levels against Synthetics assumptions, and of assumed versus measured Synthetics levels. • Gap assessment: Track SME conclusions on whether existing paper-based evaluations are sufficient. Where gaps are identified, coordinate definition of any further assessment, testing, or remediation needs, distinguishing between lifecycle management products and products in development. • Decision-ready reporting: Consolidate agreed findings, open questions, options, indicative scope, timing, and resource needs into a concise, decision-ready update with clear ownership of next steps. Technical conclusions and testing decisions remain with the accountable SMEs. Skill Requirements Mandatory: Direct, hands-on experience with nitrosamine risk assessment or related investigations for biotherapeutic products (e.g., proteins, monoclonal antibodies, cell and gene therapies, or antibody–drug conjugates). General biologics experience, or nitrosamine experience limited to Synthetics, does not meet this requirement. • Project management or coordination experience in a GMP biopharmaceutical environment, including cross-functional document review, action tracking, and evidence-based scope planning. • Working knowledge of biotherapeutic drug substance and drug product risk factors, nitrosamine assessment documentation, and the distinction between risk evaluation, confirmatory testing, and remediation. • Demonstrated ability to work effectively with scientific, quality, and regulatory SMEs; translate technical discussions into a clear plan and resource estimate; and manage sensitive scope questions without making scientific or regulatory decisions on their behalf Other Requirements Apply now Information at a Glance Why HCLTech? At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first. HCLTech is a global technology company, home to more than 230,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending September 2026 totaled $14.8 billion. Disclaimer Privacy Statement Terms of use Sitemap Raise a Grievance We use cookies on our site. Please read more about cookies policy here. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Copyright © 2026 HCL Technologies Limited Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. Required Cookies Required Cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Cookies from provider SAPasserviceprovider are required and cannot be turned off Functional Cookies These cookies provide a better customer experience on this site, such as by remembering your login details, optimizing video performance, or providing us with information about how our site is used. You may freely choose to accept or decline these cookies at any time. Note that certain functionalities that these third-parties make available may be impacted if you do not accept these cookies. Consent to all Functional Cookies Functional Cookies Provider Description Enabled Vimeo Vimeo is a video hosting, sharing, and services platform focused on the delivery of video. Opting out of Vimeo cookies will disable your ability to watch or interact with Vimeo videos. Cookie Policy Privacy Policy Terms and Conditions Consent to cookies from provider Vimeo YouTube YouTube is a video-sharing service where users can create their own profile, upload videos, watch, like, and comment on videos. Opting out of YouTube cookies will disable your ability to watch or interact with YouTube videos. Cookie Policy Privacy Policy Terms and Conditions Consent to cookies from provider YouTube Advertising Cookies These cookies serve ads that are relevant to your interests. You may freely choose to accept or decline these cookies at any time. Note that certain functionality that these third parties make available may be impacted if you do not accept these cookies. Consent to all Advertising Cookies Advertising Cookies Provider Description Enabled Google Analytics Google Analytics is a web analytics service offered by Google that tracks and reports website traffic. Cookie Information Privacy Policy Terms and Conditions Consent to cookies from provider GoogleAnalytics Google Tag Manager Google Tag Manager is a tag management system for conversion tracking, site analytics, remarketing, and more. Privacy Policy Terms and Conditions Consent to cookies from provider GoogleTagManager LinkedIn LinkedIn is an employment-oriented social networking service. We use the Apply with LinkedIn feature to allow you to apply for jobs using your LinkedIn profile. Opting out of LinkedIn cookies will disable your ability to use Apply with LinkedIn. Cookie Policy Cookie Table Privacy Policy Terms and Conditions Consent to cookies from provider LinkedIn