position in an exciting company.
_RESPONSIBILITIES_
The Director, Drug Development will:
* Initiate development programs and be the lead on specific projects.
* Specify the technical requirements for the development program,
including performance criteria, control strategies, materials,
analytical methods, test protocols, specifications, packages (clinical
and commercial) and manufacturing methods.
* Manage remotely ongoing technical programs including developing
detailed technical work plans; selecting suitable service for the
various activities; managing the performance of the vendors and
preparing periodic updates for Sr. Mgmt.
* Prepare, in conjunction with Regulatory Affairs, the Chemistry and
Manufacturing Controls sections of all IND and NDA filings for the
products that they manage.
* Assist other department team members in reviewing documents on
other projects (protocols, reports, regulatory filings, specifications
and the like).
* Support Manufacturing to ensure a smooth transfer of technologies
and products to commercial manufacturing sites.
* Create intellectual property covering pharmaceuticals products.
* Drive Innovation and proof of concept activities.
PERSON SPEC
* The preferred candidate with hold a PhD in Engineering, Pharmacy or
science and 6 or more years&#**Apply on the website**; experience in
pharmaceutical product development.
* Direct experience of pharmaceutical development, QbD and target
product profiling.
_EXPERIENCE WITH_ sterile parenteral and sustained release products
would be preferable, along with drug product device combinations
technologies (pre-filled syringes, autoinjectors, etc)
* Direct experience with authoring, reviewing and compilation of
documentation for CMC regulatory filings for pharmaceutical products
to both the US and EU.
* Broad exposure to multiple pharma technologies and knowledge of
standard dosage forms.
* Broad understanding of open label pharmacokinetic (phase one type)
studies
* General experience of IND and clinical trials
* Experience in a number of the following is desired: solid dosage
forms, controlled release formulations, combination products,
parenteral products, sustained release products, implantable and
biodegradable products, API manufacturing, and analytical chemistry.
*
_EXPERIENCE WORKING_ with and directing remotely contract
manufacturing
* Proven experience of remotely managing a technical team
* Proven project management skills for technical programs.
* Excellent communication skills and strong interpersonal skills.
* Flexibility to travel on company business when required
* A true self starter, who works effectively on their own initiative,
and is used to working in demanding environments where there is
continuous change and ambiguity
* Highly organised, with exceptional time management and
prioritisation
* Critical thinking/ evaluation of process problems
* Innovative mindset and understanding of intellectual property
generation.
* Strong work ethic
We&#**Apply on the website**;re looking for a candidate to fill this
position in an exciting company.
_RESPONSIBILITIES_
The Director, Drug Development will:
* Initiate development programs and be the lead on specific projects.
* Specify the technical requirements for the development program,
including performance criteria, control strategies, materials,
analytical methods, test protocols, specifications, packages (clinical
and commercial) and manufacturing methods.
* Manage remotely ongoing technical programs including developing
detailed technical work plans; selecting suitable service for the
various activities; managing the performance of the vendors and
preparing periodic updates for Sr. Mgmt.
* Prepare, in conjunction with Regulatory Affairs, the Chemistry and
Manufacturing Controls sections of all IND and NDA filings for the
products that they manage.
* Assist other department team members in reviewing documents on
other projects (protocols, reports, regulatory filings, specifications
and the like).
* Support Manufacturing to ensure a smooth transfer of technologies
and products to commercial manufacturing sites.
* Create intellectual property covering pharmaceuticals products.
* Drive Innovation and proof of concept activities.
PERSON SPEC
* The preferred candidate with hold a PhD in Engineering, Pharmacy or
science and 6 or more years&#**Apply on the website**; experience in
pharmaceutical product development.
* Direct experience of pharmaceutical development, QbD and target
product profiling.
_EXPERIENCE WITH_ sterile parenteral and sustained release products
would be preferable, along with drug product device combinations
technologies (pre-filled syringes, autoinjectors, etc)
* Direct experience with authoring, reviewing and compilation of
documentation for CMC regulatory filings for pharmaceutical products
to both the US and EU.
* Broad exposure to multiple pharma technologies and knowledge of
standard dosage forms.
* Broad understanding of open label pharmacokinetic (phase one type)
studies
* General experience of IND and clinical trials
* Experience in a number of the following is desired: solid dosage
forms, controlled release formulations, combination products,
parenteral products, sustained release products, implantable and
biodegradable products, API manufacturing, and analytical chemistry.
*
_EXPERIENCE WORKING_ with and directing remotely contract
manufacturing
* Proven experience of remotely managing a technical team
* Proven project management skills for technical programs.
* Excellent communication skills and strong interpersonal skills.
* Flexibility to travel on company business when required
* A true self starter, who works effectively on their own initiative,
and is used to working in demanding environments where there is
continuous change and ambiguity
* Highly organised, with exceptional time management and
prioritisation
* Critical thinking/ evaluation of process problems
* Innovative mindset and understanding of intellectual property
generation.
* Strong work ethic
We need : English (Good)
Type: Permanent
Payment:
Category: Others
