Invite for Business Minded People

[JMV1210]

Count me in! I am currently a Superintendent of Manufacturing for a pharmaceutical company, which makes sterile injectbales.

I have been working for this pharmaceutical company in NJ for 2 1/2 years.

In addition to experience I have a Bachelors of Science in Business and a Masters in Communication and Leadership from Seton Hall.

On the side, I am currently starting a online web based business. I have just completed my business plan.

Experience
Below is a overview of my experience
Nov of 00-02

Manufacturing Supervisor/ Solid Dosage Forms
Manager/Supervise for approximately 20-30 non-exempt and exempt Supervisors, Group Leaders, Tablet Production Operators and support staff of Solid Dosage Forms Manufacturing.

Responsibilities include production schedules, process, people, material, equipment, ensuring quality and regulatory standards as referenced in GMP’S, SOP’s, DEA, OSHA and Abbott standards.

Coordinates and plans daily work assignments, ensure process compliance, and maintain production schedule to meet demand requirements.

Responsible for employee training, performance, welfare, purchasing projects and equipment maintenance. Possesses effective people handling skills, motivates personnel and is responsible for communicating goals, job performance and training of direct staff.

Duties encompass production areas including Weighing, Granulation, Final Blend, Compression, Encapsulation, Film Coating and liquids.

Completes projects to improve production efficiency, upgrade/maintain equipment, improve the quality of the finished product, which includes change control.

Confirms accurate documentation for all process steps, initiates XDS electronic documents, including process deviation, NCMR’s, TSP forms, complaint investigation and change control reports.

Posses technical skill to make assessments of production aberrations.

Brings process to logical stop, recommends course of action to correct issues implements necessary steps to prevent future occurrences.

Responsible for the reconciliation and security of the controlled drug substance materials during processing and storage.

Maintains security and status for all Solid Dosage Forms and Packaging in-process security storage locations.

Provides all pertinent information by working with SAP to support financial inventory system and materials management. Insures accuracy with the movement of raw materials, finished goods and all in-process material documents.

Interacts with both internal and external vendors to accomplish established goals and projects.
Interacts routinely with QC, QA, PD, and technical Support to address/support production issues, investigations, deviations, and completes validation activity.

Writes, updates and approves revised departmental SOPs and ensures adequate training is conducted to maintain operator competency with respect to equipment and process.

Supports budgeting and capital planning by monitoring direct controllable cost, overtime, and supporting capital projects.

Experience
Oct of 1995-Nov 00

Supervisor/Team Leader/ Technical Operations
Provided supervision and leadership for approximately 10-15 non-exempt Tablet Production Operators, Group Leaders and support staff of Solid Dosage Forms Manufacturing

Perform all phases of manufacturing of Bayer products including, granulation, tablet coating, active suspensions, solutions, and final blend.

Posses strong analytical skills in proper operation of processing equipment, including: the Glatt Fluid Bed Dryer, Vector Hi-Coater, Lodige MGT Granulator, Azo Screener, Alexanderwerk RFG Sifter, and Quadro Comil.

Documentation, including: proper information recording for samples sent to Quality Assurance and Quality Control. In addition, equipment , batch information and Born On Manufacture Date (B.O.M.) are documented.

Product sampling in accordance with written procedures, including moisture testing for loss on drying (L.O.D.) to ensure our product is manageable for the compression phase.

Skilled in proper operation and maintenance of a variety of laboratory instruments and processing equipment.

Reconciliation of batch records to meet accuracy of FDA and Quality Assurance.

Advanced skills and understanding of laboratory analyses and technical processes.

Posses excellent oral and written communication skills in dealing with various levels of scientific/technical personnel.

Prepare and make recommendations to Department Manager.

Experince
Feb 94-Oct 95

Manufacturing Technician / Product Development
Team Leader Experience.

Assisting in trial runs during the compression phase and granulation phase.

Product Development processing equipment setup and breakdown.

Capsule inspection and weight checks for raw materials.

Raw material and finished product transfer.

Cleaning and sanitizing of processing equipment used for the granulation and the tablet coating process.

Inventory and stockroom control. Including material handling.

[Big Z]

<BLOCKQUOTE class="ip-ubbcode-quote"><font size="-1">quote:</font><HR>Originally posted by Orbital H2:
This looks like it would be an interesting forum, please count me in on this. I have 20 years in project management in aerospace (planes and satellites) <HR></BLOCKQUOTE>

I lost a friend on challenger, after a year building Leasat. My Most memorable experience was having the opportunity to set in the Shuttle--on 39A, (part of the launch crew for the first two satellites launched from the Shuttle.) talk about pucker power!

[Orbital H2]

Never worked the Shuttle, however I worked X33(RLV) proposal and got to climb all over the Endevear orbitor in the OPF, and watched them stack the SRBs in the VAB and got on the Atlantas on tle Launch pad to witness the umbilical mating. What a thrill. most of my life had been on the B-2 working crew life support, Sw and weapons integration. Last 8 years have been working IR payloads (not as thrilling).
I also spent some time up in Seattle (stuffed my race car into the wall at the exit of the chicane in at PIR

[RedGTS]

Put me down as well if it's still open. I am the managing partner for one of the offices of a fairly large law firm (~380 attorneys & $150-200 million in revenue). My personal expertise is in litigation, which we hopefully wouldn't need anytime soon, but I like to think I have other skills as well. Also, my firm has offices, contacts and resources all over the Southeast U.S., in D.C., and in Beijing, and those resources could be helpful.

[sbmike]

Hmmmm... I've waited to see how many people signed on to this notion and it now appears you have enough to constitute a bureaucracy. Having worked for the federal government for 35 years, I qualify as a fat cat bureaucrat so conceivably I could join your group. However, I intend to retire this year and since I already have a second career to pursue in retirement (teaching scuba diving), I'll just watch for now... Good luck!

[Steve 2]

How about a retired Technology teacher? I am also a private pilot, dabbled in real estate and am an investor. I am also an H2 owner with lots of time on my hands.

[richirich]

I own a successful insurance agency in california. been doing it for 15 years. Count me in.

[Dan]

Okay everyone, that's it. The invite is CLOSED.

We'll be getting a group together in a PM after the weekend review.

Thanks for all of the great replies!

[Andy C]

Damm

I was about to ask to be included.

17 years in the oil industry - risk analyses and assessment - last project was the largest floating deepwater drilling rig in the world (it was the second largest but the largest one sank, I was not on that project luckily) - I operated in The Congo - Brazil - Trinidad - Kazakstahn and am now based in Florida where I am starting a marine security consultancy - IMO, ISM auditing etc.

So if there is room for one more I would be interested.

[HummerLvr]

Always late but worth the wait!

If you have any room I would like to be a part of this. Not sure what I can help with, but a womens perspective is always nice.

I have been in real estate for several years and have worked at a Civil Engineering firm mainly dealing with waste water management and have tons of acknowledge about admin and marketing. Plus I own a Hummer!

If it is too late that is alrigh too, just thought I would try.

[Dan]

This is just an FYI for those who responsed to this thread.

We have gone through the replies and have included a few of you in our initial Private Message.

If you haven't already, check your PMs and give us your thoughts.

Thanks everyone for the interest in our venture.

[MONDO]

You can count me in. We manufacture custom jerseys, shorts, windbreakers, etc... for all kinds of outdoor and sports activities.

You can see more at

www.TotallyCustomJerseys.com

Thanx
Mondo

[sKauGhTiEe]

I dont mean to bring up old threads, but was curious what happened with the "biz ideas"... thanks Dan

[sKauGhTiEe]

ohh... nevermind, wait, anything?? or did it die again??

[Black 05]

They wouldn't let me in because I am from Canada

[Dan]

That's right, no stinkin canucks in this group! Actually, that was a legal thing with the LLC. All members need to be US residents.

Anyway, nothing is going on with the group. It never got off the ground for various reasons.