Replies to post #187246 on Avid Bioservices Inc (CDMO)

[bigdumbandugly]

You mean Peregrine is going to have a budget soon?? : )



yeah, they've never really been constrained by any 'budget' what with the atm puking all over like it does.

let's hope this isn't just a product of pphm simply foreseeing their expenses to soon be outracing even the atm.

partnering soon, huh?
where have i heard that one before???

i think most will need more than this job posting to be convinced of that.


edit:
no... most here won't.
my bad.

[Protector]

Biopharm,

Unless I read this wrong, this is for a NEW clinical trial (see tasks such as 'trial site selection'). I think this is for the next PIII.

Extensive background in direct management, development and supervision of a clinical operations team is required. Oncology clinical trials experience is highly desirable.

Optimizes tactical and clinical value through global site selection.
Oversees adherence to protocols and determines study completion.

Communicates regular updates to the management team on progress against timelines and budgets in support of all clinical projects.
Must be available to travel up to 30% domestically and internationally.

This person will get budgets for CT's (like the 100K$ per patient in the NSCLC clinical trail). Then he has to make sure that CT progresses on schedule (incl. enrolment) and within the granted budget.

Actually they are putting someone between the Management Team and the Clinical Affairs/Clinical research dept that will full time and exclusively manage the CT's.

If they do that it means they have a little more in petto then we think. I guy like that is not cheap. He knows much (confidentially required) he needs to travel a lot and he is the PRIMARY source of information on WHEN CT's are going to come to an end or will get interim look-ins/results depending on the type of trial.

This guy could largely enhance jbainseky's chart because he'll know the EXACT number that chart would need when it comes to patients.

[biopharm]

Job Posting Update : Peregrine : 1 new ... now we finally started to get serious with the most recent job posting of "Director/Sr. Director, Clinical Research Clinical Affairs" and now we have another job posting for "Manager, Supply Operations" ... so one may ask: Supply for a clinical trial ? or ?? : )

* Notice the new job position states relocation available and is an "Orange County" position... normally, in the past... it has always stated "Tustin" position so could there be a new facility within Orange County that is in the works...?

* Notice also we are at an all time high of 13 job postings currently listed. Some are clearly high-level positions that have never been posted or even needed before this time of "commercial need" of Bavi that has been hinted in multiple job postings...

http://en.wikipedia.org/wiki/Orange_County,_California

Orange County map...
http://en.wikipedia.org/wiki/Orange_County,_California#mediaviewer/File:OrangeCountyCA_Map.gif

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Associate Director/Director, Regulatory Affairs Reg Affairs Tustin, CA 07-Oct-2014 (PST) Full Time

Clinical Data Manager Clinical Affairs Tustin, CA 21-Sep-2014 (PST) Full Time

Clinical Trial Liaison Clinical OPS Tustin, CA 18-Oct-2014 (PST) Full Time

Clinical Trial Manager/Senior Manager Clinical OPS Tustin, CA 11-Sep-2014 (PST) Full Time

Director/Sr. Director, Clinical Research Clinical Affairs Tustin, CA 21-Oct-2014 (PST) Full Time

Laboratory Assistant Lab OPS Tustin, CA 28-Sep-2014 (PST) Full Time

Manager, Data Governance Information Technology Tustin, CA 18-Oct-2014 (PST) Full Time

Manager, Supply Operations Operations Tustin, CA 27-Oct-2014 (PST) Full Time -New!

Manufacturing Associate - Downstream Manufacturing Tustin, CA 14-Sep-2014 (PST) Full Time

Manufacturing Associate/Senior Associate Manufacturing Tustin, CA 14-Sep-2014 (PST) Full Time

Research Associate, Process Sciences Process Sciences Tustin, CA 24-Sep-2014 (PST) Full Time

Sr. Manager, Clinical Quality Assurance Quality Tustin, CA 12-Oct-2014 (PST) Full Time

Sr. Research Scientist - Pharmacology Pre-Clinical Tustin, CA 05-Oct-2014 (PST) Full Time

http://peregrineinc.applicantpro.com/jobs/

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Manager, Supply Operations

Date: Posted 28-Aug-2014, Closing 27-Oct-2014 (PST)

Department: Operations

Location: Tustin, CA

Employment Type: Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on supply chain operations expertise and pharmaceutical industry experience to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.

SUMMARY

The Manager, Supply Operations will be responsible for supply chain activities associated with supporting clinical and commercial material needs. In addition, this role is responsible for daily supply chain activities including planning and forecasting requirements for contract manufacturers and clinical product distribution, i.e. product inventory management, logistics and transportation. Position will also have primary responsibility for establishing systems and procedures for planning and inventory management of clinical and commercial material.

ESSENTIAL DUTIES AND RESPONSIBILITIES


Manage the planning and logistics of clinical material supply to support various clinical programs including multiple ISTs and late stage clinical trials.

Manage processes associated with clinical planning, forecasting, order/receipt and allocation for clinical and non-clinical needs.

Coordinate with internal stakeholders on clinical material requirements and communicate to internal and external manufacturing organizations.

Develop and optimize business processes for clinical and commercial material planning and inventory management.

Support expansion and management of ERP system associated with material planning and inventory management.

Manage key dashboard metrics for tracking supply and inventory positions.

QUALIFICATIONS

We require a Bachelor's degree in a scientific discipline with a minimum of 5 - 7 years of biotechnology or pharmaceutical industry experience working in a GMP environment supporting clinical and commercial planning activities. In addition, the selected candidate shall have the following:


Demonstrated experience in developing systems and procedures for managing inventory and production planning activities for both clinical and commercial materials.

Experience with ERP and MRP systems (e.g. SAP, Oracle, etc.) is required and experience with Microsoft Dynamics is preferred.

Experience in supply operations for biologic based products is preferred.

Experience working with 3rd party contract manufacturing organizations (CMO's) is essential.

APICS, CPIM or CPM certifications are a plus.

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.