"My Job" is an occasional item that describes a pharmaceutical manufacturing position from the first-person perspective of someone newly appointed to the job. The intent is to provide over time a picture of pharma ops career industry, in hopes that the picture will be useful in career planning. - George Miller
Metrics, in Greenville, NC, is a contract pharma development and manufacturing company that grew from a start-up analytical lab. The company recently announced the appointment of Dave Varley as director for manufacturing operations. Over a 30-year career, he has worked in pharma manufacturing and packaging positions at such companies as Burroughs Wellcome, Glaxo Wellcome, E.R. Squibb and Purdue Pharmaceuticals. Prior to joining Metrics, Varley was director for manufacturing at Bio Delivery Sciences International. We spoke at Interphex.
FiercePharma Manufacturing: What tops your to-do list as you start this job?
Varley: My top priority is ensuring that as Metrics continues to expand its commercial manufacturing capabilities, we maintain a solid foundation consisting of regulatory compliance, depth throughout various dosage forms, and quality controls.
I've had one-on-one meetings with everyone in manufacturing--from senior managers to equipment operators--for informal sit-downs. That's about 39 people. Some came to see me; I went to see others, to get to know a little about them personally as well as professionally.
What do you love about your work?
I enjoy interacting with my colleagues in Metrics' various departments to support company growth, and especially planning for new products by ensuring we have the needed production flexibility and capacity.
Why is your job a director-level position?
Because manufacturing operations need to interact with all disciplines at Metrics in both planning and execution. Plus, we're engaged with a varying client base that includes small to large pharma companies manufacturing multiple dosage forms.
In a typical week, what percentage of your time do you expect to spend on the following?
Working alone (research, admin, etc): 15 percent
Working with colleagues: 45 percent
Working with customers: 15 percent
Working with regulators: 10 percent
Other (planning): 15 percent
What will be different about Metrics' manufacturing operations after you've been on the job for a year?
Commercial manufacturing will have expanded significantly, playing a larger role in the company's profitability and being recognized internally for its can-do attitude.
What's the biggest change you've seen in pharma manufacturing over your 30 years in the business?
It takes more time and effort to implement improvements because of the necessary internal and external regulatory-related oversight. "Change" represents a real commitment in terms of time, personnel and resources.
For people who aspire to a position like yours, what's the top thing they need to know but are probably unaware of?
No matter how well mapped out your plans are, they are always subject to alteration because of influences outside of your control. Be flexible and maintain a sense of humor. If you take an unexpected hit, strive to bounce back with renewed energy.
What's the main difference between manufacturing at a contract manufacturing company versus a drug company?
Most drug companies have the luxury of being able to rely on a forecast history for each product. They can plan for capital and personnel needs and present transparent justifications for both. In the contract business, we work more in the realm of the unknown, which can include last-minute scheduling changes made by customers. Regardless of whether a change request is for a commercial product, clinic-to-market product or development, we need to respond quickly.