Sr. Scientist, CMC

4 days ago

Delhi, India Allucent Full time
At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Sr. Scientist, Chemistry Manufacturing and Controls (CMC) (Sr. Scientist, CMC) to join our A-team (hybrid*/remote). As a CMC Senior Scientist, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic, or medical device products. Responsibilities may include analysis/review of drug substance synthesis, pre-formulation and formulation evaluation, analysis of manufacture, scale-up and process validation, providing support of analytical methods development and validation, and evaluation of packaging and labeling components. The CMC Senior Scientist participates in Health Authority (HA) communications including correspondences, teleconferences, and meetings. The CMC Senior Scientist prepares CMC-related regulatory content for HA submissions, reviews and authors reports, protocols, and other scientific documents.
In this role your key tasks will include:
Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development
Guides the writing of regulatory/scientific documents written by other project team members
Has scientific knowledge of HA Regulatory Guidance and Regulations
Interacts with various HAs, including preparation of meeting and briefing documents, participation in HA meetings and preparing responses to inquiries
Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects
Is competent with electronic common technical document (eCTD) format and requirements of regulatory submissions
Manages projects as assigned and participates in meetings with clients
Prepares product development plans and/or strategies from early development through Phase 4
Actively supports staff learning & development within the company
Provides guidance and advises Project Leads, and/or Project Teams
Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources
Manages projects as a Consulting Technical Lead as assigned
Leads and/or participates in meetings with clients
Provides mentorship to team members
Requirements
To be successful, you will possess:
Requires a , , , , or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
Scientific and regulatory knowledge of drug, biologic, or device development
Critical thinking and analytical skills, as well as strong written and verbal communication skills in English
Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
Quality focus
Emotional intelligence and decision-making skills
Innovative, creative, and practical thinking including problem-solving skills
> 6 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via GoodHabitz and internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
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