Associate Director CMC

We are looking for an Associate Director, Chemistry Manufacturing and Controls (CMC) to join our A-team. As an Associate Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products. The specific experience for CMC is small molecule (solid, liquid, oral, topical, injectable (sterile products), inhalation. We are mainly focused on pre-approval 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 Associate Director leads and/or participates in Health Authority (HA) communications including correspondences, teleconferences, and meetings. The CMC Associate Director reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, and other scientific documents.   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.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 advanced scientific knowledge of HA Regulatory Guidance and Regulations  Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, 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  Has advanced understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions  Prepares product development plans and/or strategies from early development through Phase 4  Provides strategic advice in evaluating impact and necessary filing requirements and strategies for drug product post-approval changes/variations    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  Acts professionally with peers and clients, knows business etiquette  To be successful, you will possess:Requires a B.S., R.Ph., M.S., Ph.D., 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  ≥ 10 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable You have relevant work experience in a CRO or relevant industry, specific experience with small molecule (solid, liquid, oral, topical, injectable (sterile products), inhalation. You are hands on and able to author eCTD CMC Module 3.0 focused on pre-approval products. Benefits of working at Allucent include:Comprehensive benefits package per locationCompetitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid working depending on locationLeadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employeeInternal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training and internal platformsEligibility 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 employeesAbout AllucentOur mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.Apply now!Ready to bring your experience to meaningful research and Allucent, apply today or reach out to Yael Kokernoot, Sr. Manager Talent Acquisition (yael.kokernoot@allucent.com) for more information. Disclaimers:Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. “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-YK1Please mention the word ENTERTAINING and tag RNTEuNzcuMjE3LjEyNw== when applying to show you read the job post completely (#RNTEuNzcuMjE3LjEyNw==). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.

We are looking for an Associate Director, Chemistry Manufacturing and Controls (CMC) to join our A-team. As an Associate Director, CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products. The specific experience for CMC is small molecule (solid, liquid, oral, topical, injectable (sterile products), inhalation. We are mainly focused on pre-approval 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 Associate Director leads and/or participates in Health Authority (HA) communications including correspondences, teleconferences, and meetings. The CMC Associate Director reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, and other scientific documents.   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.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 advanced scientific knowledge of HA Regulatory Guidance and Regulations  Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, 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  Has advanced understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions  Prepares product development plans and/or strategies from early development through Phase 4  Provides strategic advice in evaluating impact and necessary filing requirements and strategies for drug product post-approval changes/variations    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  Acts professionally with peers and clients, knows business etiquette  To be successful, you will possess:Requires a B.S., R.Ph., M.S., Ph.D., 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  ≥ 10 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable You have relevant work experience in a CRO or relevant industry, specific experience with small molecule (solid, liquid, oral, topical, injectable (sterile products), inhalation. You are hands on and able to author eCTD CMC Module 3.0 focused on pre-approval products. Benefits of working at Allucent include:Comprehensive benefits package per locationCompetitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid working depending on locationLeadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employeeInternal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training and internal platformsEligibility 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 employeesAbout AllucentOur mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.Apply now!Ready to bring your experience to meaningful research and Allucent, apply today or reach out to Yael Kokernoot, Sr. Manager Talent Acquisition (yael.kokernoot@allucent.com) for more information. Disclaimers:Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices. “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-YK1Please mention the word ENTERTAINING and tag RNTEuNzcuMjE3LjEyNw== when applying to show you read the job post completely (#RNTEuNzcuMjE3LjEyNw==). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.