- Lead drug product validation and commercialisation activities for new pharmaceutical development projects.
- Lead continuous improvement projects for commercial products
- Support the development and manufacture of pharmaceutical dosage forms and devices.
- Consistent with FDA standards, support the process validation of to-be commercial drug products. In addition, when changes have been made to the manufacture of commercial drug products, support the re-validation of such products.
- Support the technical transfer of commercial manufacturing and analytical testing of drug products.
- Support the preparation of regulatory filings such as INDs, ANDAs, NDAs and supplements.
- Stay current with emerging technology and regulatory guidance within industry.
- Ensure effective partnership with other areas in the Company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance.
- Support the preparation of the Pharmaceutical Development & Pharmaceutical Technology budget.
- Represent Pharmaceutical Development & Pharmaceutical Technology in internal and external (vendor) meetings and teleconferences in a positive, collaborative manner.
- Contribute to the review of company policies and procedures.
- Undertake any other duties, which may be assigned by Senior Management.
-
University of Maryland Medical System Baltimore, United States**Company Description** · Renowned as the academic flagship of the University of Maryland Medical System, our Magnet-designated facility is a nationally recognized, academic medical center with opportunities across the continuum of care. Come join UMMC and discover the atmosphere ...
-
Analyst - Life Sciences Consulting
3 days ago
Latham BioPharm Group Elkridge, United States**Company Description** · Sia Partners is a next-generation management consulting firm. We offer a unique blend of AI and design capabilities, augmenting traditional consulting to deliver superior value to our clients. Counting 3,000 consultants in 19 countries, we expect to achi ...
-
Business Analyst
3 weeks ago
Global Alliant Inc Baltimore, United StatesBusiness Analyst · Hybrid Largo, MD (2 days onsite in a week) · Rate- $70/hr C2C · Start Date: Monday, June 10, 2024 End Date: June 30, 2025 with option to extend. · Interview- Thursday, May 22, 2024 · Business hours of 8:00 a.m. - 6:00 p.m, Monday through Friday on a regula ...
-
Business Analyst
2 weeks ago
Global Alliant Inc Baltimore, United StatesBusiness Analyst · Hybrid Largo, MD (2 days onsite in a week) · Rate- $70/hr C2C · Start Date: Monday, June 10, 2024 End Date: June 30, 2025 with option to extend. · Interview- Thursday, May 22, 2024 · Business hours of 8:00 a.m. - 6:00 p.m, Monday through Friday on a regula ...
-
Head of Global Regulatory Intelligence
3 weeks ago
Daiichi Sankyo Baltimore, United StatesHead of Global Regulatory Intelligence & Policy · in · Remote · at · Daiichi Sankyo · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and ad ...
-
Senior Director, Global Regulatory Intelligence
3 weeks ago
Daiichi Sankyo Baltimore, United StatesSenior Director, Global Regulatory Intelligence & Policy · in · Basking Ridge · at · Daiichi Sankyo · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standard ...
-
Field Case Manager
5 days ago
Genex Services Baltimore, United StatesCompany Overview: · The Enlyte Family of Businesses · Mitchell | Genex | Coventry · Enlyte is the parent brand of Mitchell, Genex and Coventry, an organization unlike any other in the Property & Casualty industry, bringing together three great businesses with a shared vision ...
-
Senior Director, Global Regulatory Intelligence
3 weeks ago
Daiichi Sankyo Company, Limited Baltimore, United StatesHead of Global Regulatory Intelligence & Policy page is loaded · Head of Global Regulatory Intelligence & Policy · Apply · remote type · Hybrid Work Arrangement · locations · Basking Ridge, NJ · Remote by Design Home Office · time type · Full time · posted on · Posted ...
-
Sr. Project Manager
4 weeks ago
PeopleSuite Baltimore, United StatesScope of Position · Interact with Business Development and Contracts group, Clients, and Operational teams to onboard new projects, identify resources required to support the project deliverables, and schedule, and track projects to completion. For assigned projects (R&D and Com ...
-
Global Regulatory Strategy Lead
3 weeks ago
Bill & Melinda Gates Foundation Baltimore, United StatesGlobal Regulatory Strategy Lead page is loaded · Global Regulatory Strategy Lead · Apply · locations · Cambridge, MA · time type · Full time · posted on · Posted 4 Days Ago · job requisition id · B020286 · "We are focused on results. Those that can be measured. And tho ...
-
Associate Director
6 days ago
AusBiotech Baltimore, United StatesAssociate Director / Director of Cell and Gene Therapy · 22 Mar 2024 · The Position · BioCurate is a bold, collaborative venture, dedicated to translating Australian medical research and delivering health and economic benefits to the world. The team work closely with the shareho ...
-
Bioprocess Engineer
1 week ago
Blackwomenintech Baltimore, United StatesGSK is currently looking for a Bioprocess Engineer MSAT to join our team in Rockville, MD. In this role, you'll provide technical support for biopharmaceutical product manufacturing. This individual will support technology transfer of new products, product lifecycle management of ...
-
Scientific Marketing Manager
2 weeks ago
Pharmaron Baltimore, United StatesJob Description · Job DescriptionWho We Are Looking For: · We are looking for a Scientific Marketing Manager to join our Growth team at US Pharmaron. This role provides an exciting opportunity for a motivated individual to work on initiatives from inception to completion that mak ...
-
Management Analyst
1 week ago
9th Way Insignia Baltimore, United States Full timeCompany Introduction: · 9th Way Insignia is a service-disabled, veteran-owned small business bringing transformative technology to our government customers so they can achieve their missions. Our specialties include cybersecurity, cloud modernization, software development, data ...
-
Senior Consultant, FAR
3 weeks ago
Sia Partners Elkridge, United StatesLatham BioPharm Group · Latham BioPharm Group, a part of Sia Partners, provides the insight, knowledge, and network to unite teams and technologies in the Life Sciences. We provide the depth of expertise necessary to advance programs, by providing a range of life science service ...
-
City Clerk
3 weeks ago
City of College Park College Park, United StatesCity Clerk · The City of College Park, a progressive and diverse community of 35,000 in the state of Maryland, seeks an experienced professional to execute the duties of the City Clerk. This executive-level position reports to the City Manager and will oversee and manage the Cit ...
-
Sales Engineer
2 weeks ago
Chesapeake Mission Critical Beltsville, United States Full timeChesapeake Mission Critical is looking for a detail oriented Sales Engineer to join our fast-paced, energetic organization. The ideal candidate will have 3 plus years' experience in technical sales, excellent customer service and follow-up skills. · If you love cutting technology ...
-
Registered Nurse Case Manager
3 weeks ago
The Arora Group Annapolis, United StatesRegistered Nurse Case Manager · Nurse · Currently recruiting a Registered Nurse Case Manager in Annapolis, Maryland to provide care to active duty American heroes, their families, and military retirees at Naval Branch Health Clinic Annapolis. Registered Nurse Case Manager is full ...
-
City Clerk
1 week ago
City of College Park College Park, United StatesJob Description · Job DescriptionCity Clerk · The City of College Park, a progressive and diverse community of 35,000 in the state of Maryland, seeks an experienced professional to execute the duties of the City Clerk. This executive-level position reports to the City Manager and ...
CMC Manager - Dundalk, United States - The RFT Group
Description
3 weeks agoBe among the first 25 applicants
Direct message the job poster from The RFT Group
unique authority in executive search for global based innovation driven drug development companies
Our client is young ambitious pharmaceutical company with a strong record of success in drug development.
The newly appointed CMC Manager will report to the Associate Director – Technical Operations and will manage pharmaceutical development and pharmaceutical technology projects to deliver development pipeline and support existing commercial products.
Manage pharmaceutical development projects primarily with respect to validation and commercialization of new products. Manage pharmaceutical technology projects, primarily coordinating continuous improvement activities at CMOs.Job Spec
The preferred candidate will have a degree in Chemistry, Analytical Chemistry, Pharmacy or related equivalent at 2.1 or higher master's degree in chemistry or related equivalent PhD in Chemistry or related equivalent
At least 5 years practical experience of working in pharmaceutical development or manufacturing. At least 2 years practical experience of drug product Process Performance Qualifications and associated activities. Hands on experience is required in the manufacture of drug products, and execution of PPQ / Validation batch manufacture.
Hands on experience is required in the manufacture of drug products, and execution of PPQ / Validation batch manufacture.
You will have a strong knowledge of ICH, FDA and EMA Process Performance Qualification and Process Validation guidelines, as well as a strong knowledge of ICH, FDA and EMA guidelines relating to Pharmaceutical Development
10+ years practical experience of working in pharmaceutical development or manufacturing. At least 5 years practical experience of drug product Process Performance Qualifications and associated activities. Practical experience of packaging Line Trials and Validations. Practical knowledge and experience of drug product Serialization requirements
Preparation and execution of Process Performance Qualification protocols and reports for Oral Solid Dosage forms. Good knowledge of statistical considerations ie Design of Experiments, ASTM E2709/E2810
At least 2 years' experience managing pharmaceutical projects at a Contract Manufacturing organisation. Use of DoE methodology in in evaluation and determination of process Design Space and Control Strategies. Experience writing Module 3 Regulatory Submission documentation.
Demonstrable IT skills ie Office. Knowledge and understanding of statistical software applications ie MiniTab. Proven communication skills (written and verbal). Proven ability to maintain high standards of work and attention to detail. Demonstrable planning, organization and time management skills. Demonstrable ability to work with and influence CMOs.
Must be able to work individually and as part of a team. Ability to work proactively and under time constraints. Good interpersonal skills
Cv to
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Engineering, Manufacturing, and Research
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at The RFT Group by 2x
Get notified about new
Operations Manager
jobs in
Dundalk, County Louth, Ireland .
Dundalk, County Louth, Ireland
3 days ago
Retail Store Manager- Laurence Town Centre, Drogheda
Dundalk, County Louth, Ireland
1 week ago
Newry, Northern Ireland, United Kingdom
1 week ago
Kilkeel, Northern Ireland, United Kingdom
1 week ago
Kilkeel, Northern Ireland, United Kingdom
1 week ago
Julianstown, County Meath, Ireland
4 days ago
Newry, Northern Ireland, United Kingdom
2 weeks ago
Dundalk, County Louth, Ireland
4 weeks ago
Dundalk, County Louth, Ireland
2 weeks ago
We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
