Sr. Scientist, CMC
4 days ago
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 Director, Chemistry Manufacturing and Controls (CMC) (Director, 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 membersRequirements
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 > 4 years’ post-degree of directly relevant experience in drug, biologic, or device development desirableBenefits
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 employeesDisclaimers:
*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.”
#LI-AH1
-
Scientist - CMC (Analytical)
2 months ago
india Ferring Pharmaceuticals Full timeJob Description: Role : Scientist Reports to : Associate Director - CMC (Analytical) Location : Hyderabad, India Purpose of the Role : Work both as individual contributor and in collaboration with team to facilitate & drive timely achievement of CMC & R&D objectives, from CMC (Analytical) function. Qualification : Ph.D (preferred), M. Pharma/M.Sc in...
-
Assistant Scientist
2 months ago
india Ferring Pharmaceuticals Full timeJob Description: Position: Assistant Scientist / Scientist - CMC (Formulation) - Injectables Reporting to: Lead scientist/Associate Director -CMC Location: Hyderabad, India Education/Qualifications: M. Pharm/Ph.D from premier institute. Experience: At least 7-9 years of industrial research experience, in the field of formulation development for...
-
Assistant Scientist
1 week ago
India Ferring Pharmaceuticals Full timeJob Description: Position : Assistant Scientist / Scientist - CMC (Formulation) Reporting to : Lead scientist/Associate Director -CMC Location : Hyderabad, India Education/Qualifications : M. Pharm/Ph.D from premier institute. Experience : At least 7-9 years of industrial research experience, in the field of formulation development for differentiated...
-
Sr Data Scientist
2 weeks ago
India QRC Group, LLC Full timeJob Description Sr Data Scientist with work experience in programming, coding, system design and architecture, algorithms and data structures. Experience with statistical software, coding languages (e.g. R, MATLAB, SAS, Python) and database languages (e.g. SQL). Experience articulating business questions and using programming techniques to establish business...
-
Sr. Associate Regulatory Affairs
3 weeks ago
india QRC Group, LLC Full timeJob Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...
-
Sr Data Scientist
3 weeks ago
india QRC Group, LLC Full timeJob Description Sr Data Scientist with work experience in programming, coding, system design and architecture, algorithms and data structures. Experience with statistical software, coding languages (e.g. R, MATLAB, SAS, Python) and database languages (e.g. SQL). Experience articulating business questions and using programming techniques to establish...
-
Sr Data Scientist
1 month ago
india QRC Group, LLC Full timeJob Description Sr Data Scientist with work experience in programming, coding, system design and architecture, algorithms and data structures. Experience with statistical software, coding languages (e.g. R, MATLAB, SAS, Python) and database languages (e.g. SQL). Experience articulating business questions and using programming techniques to establish...
-
Sr. Associate Regulatory Affairs
4 weeks ago
india QRC Group, LLC Full timeJob Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...
-
Value Added Services
2 months ago
India DSRP Enterprises Full time**Responsibilities**: 1. To promote and sell maintenance services a) To convert AMC (Annual Maintenance Contracts) to CMC (Comprehensive Annual Maintenance Contracts), b) Convert non-AMC, CR (Chargeable Repairs), Out of warranty instruments in AMC / CMC c) To promote PM kits (Preventive Maintenance Kits) to CR and AMC customers 2. To promote and sell...
-
Value Added Services
3 days ago
India DSRP Enterprises Full time**Responsibilities**: 1. To promote and sell maintenance services a) To convert AMC (Annual Maintenance Contracts) to CMC (Comprehensive Annual Maintenance Contracts), b) Convert non-AMC, CR (Chargeable Repairs), Out of warranty instruments in AMC / CMC c) To promote PM kits (Preventive Maintenance Kits) to CR and AMC customers 2. To promote and sell...
-
Sr. Data Scientist
4 weeks ago
india Birlasoft Full timeHello, Greetings! @Birlasoft #hiring for Data Scientist (8.5 to 14years) Location: PAN BSL location Notice Period: Immediate to 30days Max Skillset: Python, R, Data wrangling, Natural Language API Sharing below JD: 6 years of relevant work experience as a data scientist Experience designing and building statistical forecasting models. Experience designing...
-
Value Added Services
2 weeks ago
India DSRP Enterprises Full timeResponsibilities:To promote and sell maintenance servicesa) To convert AMC (Annual Maintenance Contracts) to CMC (Comprehensive Annual Maintenance Contracts),b) Convert non-AMC, CR (Chargeable Repairs), Out of warranty instruments in AMC / CMCc) To promote PM kits (Preventive Maintenance Kits) to CR and AMC customersTo promote and sell Validation servicesa....
-
Scientist Sr II
1 month ago
india H.B. Fuller Full timeAs the largest pureplay adhesives company in the world, H.B. Fuller’s (NYSE: FUL) innovative, functional coatings, adhesives and sealants enhance the quality, safety and performance of products people use every day. Founded in 1887, with 2023 revenue of $3.5 billion, our mission to Connect What Matters is brought to life by more than 7,000 global team...
-
Scientist Sr II
3 weeks ago
india H.B. Fuller Full timeAs the largest pureplay adhesives company in the world, H.B. Fuller’s (NYSE: FUL) innovative, functional coatings, adhesives and sealants enhance the quality, safety and performance of products people use every day. Founded in 1887, with 2023 revenue of $3.5 billion, our mission to Connect What Matters is brought to life by more than 7,000 global team...
-
Data Scientist
1 month ago
india Brillio Full timeAbout Brillio: Based out of Silicon Valley, Brillio, a leading technology consulting and services company, continues to be at the forefront of data science innovation in 2023. Leveraging cutting-edge technology and advanced analytics, Brillio empowers businesses with data-driven insights to make informed decisions, optimize operations, and achieve...
-
India Benovymed Healthcare Private Ltd Full timeJob Position :Principal Data Scientist / Sr Data Scientists /Data Scientist / Jr. Data Scientist / Data Science Intern / Machine Learning Engineer-Global Tech AI Health Startup. Joining : Immediately. Job Location : Delhi NCR, India.Global HQ, Benovymed Global Technology Development and Innovation Center & Benovymed Global R and D, and AI Health Innovation...
-
india Benovymed Healthcare Private Ltd Full timeJob Position :Principal Data Scientist / Sr Data Scientists /Data Scientist / Jr. Data Scientist / Data Science Intern / Machine Learning Engineer-Global Tech AI Health Startup. Joining : Immediately. Job Location : Delhi NCR, India.Global HQ, Benovymed Global Technology Development and Innovation Center & Benovymed Global R and D, and AI Health Innovation...
-
india Benovymed Healthcare Private Ltd Full timeJob Position :Principal Data Scientist / Sr Data Scientists /Data Scientist / Jr. Data Scientist / Data Science Intern / Machine Learning Engineer-Global Tech AI Health Startup. Joining : Immediately. Job Location : Delhi NCR, India.Global HQ, Benovymed Global Technology Development and Innovation Center & Benovymed Global R and D, and AI Health Innovation...
-
Data Science Engineer
1 week ago
india RubyPy Full timeJob Description- Designation : Data Science DeveloperLocation : Indore | OnsiteSkills : Data Science, Machine Learning, Deep Learning, NLP, Python, Flask, Numpy, Panda.Sr. Data Scientist Responsibilities :- Formulating, suggesting, and managing data-driven projects which are geared at furthering the business's interests.- Collating and cleaning data from...
-
GenAI Senior Data Scientist
4 days ago
india Simple Solutions Full timeJob Description GenAI Senior Data Scientist As a Senior Data Scientist, you will collaborate with the Data Science and Machine Learning team and will create data science, machine learning, and AI solutions to better address the needs of our constituents (students, alumni, faculty, researchers, staff, and community at large). You will experiment with...
